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anakinra (n=59) vs. control (n=57)
randomized controlled trial
usual care plus anakinra (200 mg twice a day on days 1–3, 100 mg twice on day 4, 100 mg once on day 5)
usual care alone
COVID-19 mild to moderate
patients with mild-to-moderate COVID-19 pneumonia, severe acute respiratory syndrome coronavirus 2 infection confirmed by real-time RT-PCR, requiring at least 3 L/min of oxygen by mask or nasal cannula but without ventilation assistance, a score of 5 on the WHO Clinical Progression Scale (WHO-CPS), and a C-reactive protein serum concentration of more than 25 mg/L not requiring admission to the intensive care unit at admission to hospital
open-label
16 university hospitals in France
anticoagulant, curative dose (n=1190) vs. anticoagulant, prophylactic dose (n=1054)
randomized controlled trial
therapeutic-dose anticoagulation with heparin
usual care pharmacological thromboprophylaxis
COVID-19 mild to moderate
open-label
prematurely discontinued after a planned adaptive analysis of data from 1398 patients showed that the prespecified stopping criteria for superiority of therapeutic-dose anticoagulation had been reached in both the high and low d-dimer cohorts
azithromycin (n=172) vs. standard of care (n=159)
randomized controlled trial
azithromycin plus hydroxychloroquine
standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days
hydroxychloroquine
standard care plus hydroxychloroquine at a dose of 400 mg twice dailyThe use of glucocorticoids, other immunomodulators, antibiotic agents others than macrolides , and antiviral agents was allowed
3 arms: hydroxychloroquine plus azythromycin, hydroxychloroquine monotherapy and standard of care
COVID-19 mild to moderate
open-label
Brazil, 55 sites
Randomization was performed in blocks of six and was stratified according to the use or nonuse of supplemental oxygen at the time of randomization
azithromycin (n=107) vs. standard of care (n=99)
randomized controlled trial
azithromycin
azithromycin 500 mg/24 h for 7 days
standard of care
3 arms azithromycin, clarithromycin or standard of care
COVID-19 mild to moderate
open-label
1 centre, Egypt
azithromycin plus hydroxychloroquine (n=217) vs. standard of care (n=227)
randomized controlled trial
Hydroxychloroquine plus azithromycin
Standard of care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days.
Standard of care
The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed.
3 arms: hydroxychloroquine plus azythromycin, hydroxychloroquine monotherapy and standard of care (1:1:1 ratio). All patients received standard of care.
COVID-19 mild to moderate
Adult patients (18 years and older) with suspected or confirmed COVID-19 admitted to inpatients units and intensive care units. Patients using non-invasive ventilation or invasive mechanical ventilation were excluded. Patients with previous use of chloroquine, hydroxychloroquine, azithromycin or any other macrolide for more than 24h before enrollment were excluded.
Open-label.
Multicenter; 55 sites in Brazil.
Scores on the scale were defined as follows: a score of 1 indicated not hospitalized with no limitations on activities; 2, not hospitalized but with limitations on activities; 3, hospitalized and not receiving supplemental oxygen; 4,hospitalized and receiving supplemental oxygen;5, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 6, hospitalized and receiving mechanical ventilation; and 7, death.
3 interim analyses planned, only the first one was conducted.
azvudine (n=10) vs. antiviral and associated therapy (n=10)
randomized controlled trial
Azvudine
Oral azvudine tablets 5 mg/day (five tablets once a night) and symptomatic treatment.
Standard antiviral
interferon alpha, kaletra and ribavirin, chloroquine phosphate, and hydroxychloroquine sulfate
When patients developed clinical symptoms and signs, such as fever and cough, patients in both groups were treated with febrifuge or cough mixture, which was called symptomatic treatment.
COVID-19 mild to moderate
Confirmed COVID-19 by RT-PCR. The definition of mild COVID-19 was patients with mild clinical symptoms and without signs of pneumonia in imaging; the definition of commonCOVID-19 was patients with fever, respiratory, or other related symptoms, and with signs of pneumonia in imaging. Patients with one of the following conditions: respiratory failure and the need for mechanical ventilation; shock; intensive care unit (ICU) monitoring and treatment for other organ failures were excluded.
Open-label
Single center, Guangshan County People’s Hospital, China.
bromhexine (n=12) vs. standard of care (n=6)
randomized controlled trial
Bromhexine hydrochloride
Patients in the treatment group received BRH tablets (32 mg t.i.d.) three times per day after meals for 14 consecutive days. Treatment was discontinued once the patient met the discharge criteria.
Standard of care
Antiviral drugs, including arbidol hydrochloride granules (0.1 g–0.2 g t.i.d.) and recombinant human interferon α 2b spray (0.083 mL t.i.d.)
All patients were divided into the treatment group (BRH group) or the control group (control group) at a 2:1 ratio. All participants were treated with antiviral drugs, including arbidol hydrochloride granules (0.1 g–0.2 g t.i.d.) and recombinant human interferon α 2b spray (0.083 mL t.i.d.), on the doctors’ discretion according to China’s Novel Coronavirus Pneumonia Diagnosis and Treatment Plan.
COVID-19 mild to moderate
Hospitalized patients with COVID-19 (≥ 18 years but ≤ 80 years) with confirmed or clinically suspected mild or moderatecoronavirus pneumonia (COVID-19), based on China’s Novel Coronavirus Pneumonia Diagnosis and Treatment Plan.
Open-label.
Single center, The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.
Clinical recovery was defined as clinical symptoms (fever and respiratory symptoms) returning to normal over 48 hours. Disease deterioration was defined as the presence of respiratory distress, respiratory rate ≥ 30 times/minute, oxygen saturation ≤ 93% in the resting state, and oxygenation index ≤ 300 mmHg.
Cannabidiol (n=53) vs. placebo (n=52)
randomized controlled trial
Cannabidiol
300mg/day Cannabidiol plus standard of care during 14 days.
Placebo
Placebo plus standard of care during 14 days.
COVID-19 mild to moderate
Double-blind.
2 sites in Sao Paulo, Brazil.
Primary endpoint was measured with the COVID-19 Scale or the natural course of the resolution of typical clinical symptoms, and assessed on days 14, 21, and 28 after enrollment.
casirivimab/imdevimab (Ronapreve) (n=912) vs. placebo (n=452)
randomized controlled trial
REGEN-COV Casirivimab and imdevimab
2.4 g or 8.0 gREGEN-COV (1.2 g casirivimab and1.2 g imdevimab)
Placebo
Single intravenous dose.
3 arms ratio 1:1:1 : 2.4 g REGEN-COV (1.2 g casirivimab and1.2 g imdevimab), 8.0 g REGEN-COV (4.0 g casirivimab and 4.0 g imdevimab), or placebo as a single intravenous dose. Standard-of-care treatments for Covid-19, per the investigator, were permitted.
COVID-19 mild to moderate
Double-blind.
103 sites in the United States, Brazil, Chile, Mexico, Moldova, and Romania
Primary endpoints were tested hierarchically.
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.* Trial was stopped earlier than planned (due to low enrollment prior to the surge associated with the Delta variant).
clarithromycine (n=99) vs. standard of care (n=99)
randomized controlled trial
clarithromycin
500mg /12 h for 7 days
standard of care
3 arms azithromycin, clarithromycin or standard of care
COVID-19 mild to moderate
open-label
1 centre, Egypt
colchicine (n=52) vs. standard of care (n=51)
randomized controlled trial
Colchicine
Standard of care plus initial dose of 1.5 mg (1 mg and 0.5 mg two hours after) of colchicine, followed by 0.5 mg every 12 hours during the next 7 days and 0.5 mg every 24 hours until the completion of 28 days of total treatment.
Standard of care
Both colchicine and control group patients received the recommended standard treatment in the study: dexamethasone (6 mg once a day for 10 days) in patients who required supplemental oxygen (WHO scale ≥4). Remdesivir was administered for 5 days following the Spanish Agency of Medications and Pharmaceutical Products recommendation which included: time from symptoms onset <7 days; two or more measurements of oxygen saturation below 94% on room air, respiratory rate >24 breaths/min without supplemental oxygen or Pa02/Fi02<300 (Kirby index). Tocilizumab was administered at a single dose of 600 mg and baricitinib at 4 mg/day for 14 days. The need for tocilizumab or baricitinib was established according to the physician on care criteria.
COVID-19 mild to moderate
Exclusion of patient needing mechanical ventilation, non-invasive or invasive, or extracorporeal membrane oxygenation support (ECMO).
Open-label, randomized.
Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain.
multiple testing102 patients
convalescent plasma treatment (n=80) vs. placebo (n=80)
randomized controlled trial
Convalescent plasma
250 ml of convalescent plasma with an IgG titer greater than 1:1000 against SARS-CoV-2 spike (S) protein (COVIDAR IgG, Instituto Leloir, Argentina).
Placebo
250 ml of placebo (0.9% normal saline).
Convalescent plasma or placebo was administered less than 72 hours after the onset of symptoms, and the infusions were given over a period of 1.5 to 2.0 hours. None of the patients received any experimental therapy for Covid-19 besides convalescent plasma.
COVID-19 mild to moderate
Patients who were 75 years of age or older, irrespective of current coexisting conditions, or between 65 and 74 years of age with at least one coexisting condition were identified and assessed for eligibility. At the time of screening for SARS-CoV-2 by reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay, eligible patients had had at least one of each sign or symptom in the following two categories for less than 48 hours: a temperature of at least 37.5, unexplained sweating, or chills; and dry cough, dyspnea, fatigue, myalgia, anorexia, sore throat, dysgeusia, anosmia, or rhinorrhea.
Double-blind
Clinical sites and geriatric units in Argentina
The trial was stopped early at 76% of its projected sample size because cases of Covid-19 in the trial region decreased considerably and steady enrollment of trial patients became virtually impossible.
discontinuation of ACEI/ARB (n=371) vs. continuation of ACEI/ARB (n=369)
randomized controlled trial
Discontinuation of ACEIs or ARBs
Other drugs could replace these agents at the discretion of the treating physician.β-Blockers were maintained in patients already taking them for heart failure.
Continuation of ACEIs or ARBs
The study protocol did not recommend any specific treatment modification beyond discontinuing or continuing use of ACEIs or ARBs.
COVID-19 mild to moderate
Hospitalized patients with confirmed COVID-19 diagnosis, using ACEI or ARBs; Age ≥18 years; Using no more than 3 antihypertensive drugs; Ability of patient (or legal representative) to provide informed consent.
Open-label.
Multicenter, 29 sites in Brazil.
Outcome calculated for each patient by subtracting the number of days in the hospital and the number of days from death until the end of follow-up from 30 days.
Ensitrelvir (XOCOVA) (n=-9) vs. placebo (n=-9)
randomized controlled trial
ensitrelvir 125 mg or 250 mg
loading dose of ensitrelvir on day1 (375 mg for the 125 mg group and 750 mg for the 250 mg group), followed by the maintenance dose (125 mg for the 125 mg group and 250 mg for the 250 mg group) on days 2 through 5 without dose modification
placebo
COVID-19 mild to moderate
A majority of the patients in the ITT population had been vaccinated (ensitrelvir 125 mg, 14 [87.5%]; ensitrelvir 250 mg, 12 [85.7%]; and placebo, 123 12 [70.6%])
double blind
japan, 56 centers
favipiravir (n=193) vs. lopinavir/ritonavir (n=187)
randomized controlled trial
favipiravir
Favipiravir 1600 mg stat and then 600 mg every 8 h plus hydroxychloroquine 200 mg twice a day for 1 week.
lopinavir/ritonavir
single dose of hydroxychloroquine 400 mg followed by 100 400 Lopinavir/Ritonavir twice a day for 1 week
Later on, during the trial (31 May 2020), in light of emerging evidence, daily hydroxychloroquine in the Favipiravir group was reduced to a single dose of 400 mg as in control group
COVID-19 mild to moderate
open-label
20 centres, Iran
favipiravir (n=107) vs. placebo (n=49)
randomized controlled trial
Favipiravir
1800 mg twice a day on Day 1, followed by 800 mg twice a day for up to 13 days.
placebo
1:2 ratio. Seven patients in the placebo group were switched to treatment with favipiravir during Days 2–8 due to a lack of efficacy.
COVID-19 mild to moderate
Single blind.
Japan
Improvement was defined as follows:(1) improvement in temperature was defined as axillary temperature falling to =< 37.4 C and remaining at =< 37.4 C for at least 24 h (temperature recordings taken within 4 h after use ofan antipyretic were excluded); (2) improvement in SpO2 was defined as SpO2 remaining >= 96%for at least 24 h without the use of oxygen therapy; (3) improvement on chest imaging was defined as improvement in chest imaging findings taken at least 24 h after the previous image judged to be the worst; and (4) recovery to SARS-CoV-2-negative was defined as two consecutive negative results on qualitative tests by nucleic acid amplification separated by at least 24 h.
favipiravir (n=112) vs. standard of care (n=56)
randomized controlled trial
favipiravir
1800 mg BID on day 1, followed by 800 mg BID for up to9 days)
standard of care
umifenovir intranasal interferon alpha-2b, orhydroxychloroquine) for up to 10 days
COVID-19 mild to moderate
open label
10 centres, Russia
favipiravir (n=125) vs. standard of care (n=129)
randomized controlled trial
Favipiravir and Hydroxychloroquine
Favipiravir: 1800 mg twice daily for one day, followed by 800mg (total days of therapy is 10 days or till hospital discharge)Hydroxychloroquine (400mg) twice daily on day 1; for days 2-5 (200mg) twice daily.
standard of care
COVID-19 mild to moderate
open label
9 centers, Saudi Arabia
Moderate or Severe confirmed COVID-19
Trial stopped for futility after the first interim analysis
favipiravir (n=75) vs. standard of care (n=75)
randomized controlled trial
favipiravir
3,600 mg (1,800 mg BID) (Day 1) 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days
sandard of care
Drugs thought to have antiviral activity against SARS CoV2 (including hydroxychloroquine) were prohibited
COVID-19 mild to moderate
open label
12 centres, India
Clinical cure was based on clinician assessment and defined as recovery of fever (axillary temperature ≤97.8°F), respiratory rate of ≤20 breaths/minute, oxygen saturation ≥98% without oxygen supplementation (which was later revised to align with the discharge criterion of ≥95% oxygen saturation issued by the Indian Ministry of Health prior to the start of the study), and cough relief (mild or no cough) maintained for ≥72 hours.
favipiravir (n=50) vs. standard of care (n=50)
randomized controlled trial
favipiravir
3200 mg (1600 mg 12 hourly) loading dose on day-1 followed by 1200 mg maintenance dose (600 mg 12 hourly daily) on day-2 to day-10
standard of care
oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10
COVID-19 mild to moderate
open label, randomized
2 centres, Egypt
favipiravir (n=20) vs. standard of care (n=20)
randomized controlled trial
favipiravir
Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or Favipiravir 1800 mg BID on Day 1 followed by 800 mg BID on Days 2-14 (1800/800 mg)
standard of care
COVID-19 mild to moderate
open label
6 centres, Russia
adaptative phase II/III3 arms : favipiravir low dose, or favipiravir high dose or SOC
favipiravir (n=100) vs. standard of care (n=100)
randomized controlled trial
favipiravir
1600 mg 2 times a day; on days 2-14 of treatment - 600 mg 2 times a day
standard of care
COVID-19 mild to moderate
open label
5 centres, Russia
Rate of clinical status improvement by categorical ordinal scale of clinical status improvement by 2 or more categories by Day 10 WHO Ordinal Scale for Clinical Improvement (WHO-OSCI), 0 - uninfected (There are no clinical and virological signs of infection), 8 - dead, higher scores mean a worse outcome
Article published in Russian. Results extracted from clinicaltrials.gov.
favipiravir plus interferon (n=44) vs. standard of care (n=45)
randomized controlled trial
favipiravir with interferon beta-1b by inhalation aerosol
favipiravir : 1600 mg (Day 1) followed by 600mg twice a day for a maximum of 10 daysinterferon beta-1 : 8million IU (0.25µg) twice a day for 5 days (through nebulization)
standard of care
HCQ 400 mg twice per day on the day 1, then 200 mg twice per day for 7 days
COVID-19 mild to moderate
open label
1 center, Oman
200 patients needed; due to logistical and financial constraints, only a total of 89 COVID-19 patients were enrolled into the study
heparin at therapeutic dose (n=228) vs. standard of care (n=237)
randomized controlled trial
Therapeutic heparin (high dose nomogram)
Unfractionated heparin OR low molecular weight heparin (tinzaparin 175 U/kg once per day, enoxaparin 1.5 mg/kg once per day or 1 mg/kg twice per day or dalteparin 200 U/kg administered until discharged from hospital, 28 days or death
Prophylactic heparin
Prophylactic subcutaneous heparin (low molecular weight heparin or unfractionated heparin) adjusted for body mass index and creatinine clearance.
Prophylactic doses of heparin were thus restricted to evidence based protocols for the prevention of venous thromboembolism for medical patients admitted to hospital. Study treatment was started within 24 hours after randomisation and continued until the first of hospital discharge, day 28, study withdrawal, or death. If a participant was admitted to ICU, continuation of the allocated treatment was recommended.
COVID-19 mild to moderate
Moderate illness was defined as admission to hospital ward level of care (ie, not to ICU), not already mechanically ventilated, and not imminently requiring mechanical ventilation or critical care. D-dimer levels were required to be above the upper limit of normal of the local hospital in the presence of an oxygen saturation ≤93% on room air, or ≥2 times the upper limit of normal irrespective of oxygen saturation. Participants were excluded if they had substantial bleeding risks, an absolute indication for or any contraindication to heparin anticoagulation based on care team judgment, were pregnant, or ift hey had already experienced, or would imminently experience any component of the primary outcome (all cause death, non-invasive or invasive mechanical ventilation, or ICU admission).
Open-label, randomized.
Multicenter: 28 hospitals in Brazil, Canada, Ireland, Saudi Arabia, United Arab Emirates, and US.
462 participants
hydroxychloroquine (n=221) vs. standard of care (n=227)
randomized controlled trial
hydroxychloroquine at a dose of 400 mg twice daily
hydroxychloroquine [400mg 2x/day, 12/12h] for 7 days
standard of care
The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed
3 arms: hydroxychloroquine plus azythromycin, hydroxychloroquine monotherapy and standard of care
COVID-19 mild to moderate
open-label
Brazil, 55 sites
Randomization was performed in blocks of six and was stratified according to the use or nonuse of supplemental oxygen at the time of randomization
Indomethacin (n=103) vs. paracetamol (n=107)
randomized controlled trial
Indomethacin
Standard of care plus indomethacin 75mg (once a day for BMI<30, twice a day for BMI>30). A proton pump inhibitor was also added along with indomethacin.
Paracetamol
Standard of care plus paracetamol 650mg four times a day.
All patients in both groups received standard of care (doxycycline, ivermectin, vitamin C, zinc, cough syrup).
COVID-19 mild to moderate
Hospitalized adult patients (20-90), with positive RT-PCR, normal KFT, normal LFT, oxygen saturation 94% or more.
Open-label.
Panimalar Medical College, Chennai, India.
Follow-up through a telephonic enquiry.
interferon / TFF2 (n=40) vs. standard of care (n=40)
randomized controlled trial
Interferon kappa plus TFF2
Both proteins (5 mg TFF2 plus 2 mg IFN-k) were dissolved in 5 mL sterilized water, and the combination aerosol was delivered to the patient for 20 to 30 min by a nasal mask driven by a medical compressed air atomizer (YUWELL, 403M). The aerosol inhalation treatment started from the first day of hospitalization and was administered 6 times every 24 h.
Standard care
Standard care alone. Standard care included symptomatic treatment with hydroxychloroquine, antibiotic agents, vasopressors, antifever medicine, vitamin C, immune enhancers, or traditional Chinese medicines.
Both groups received standard of care.
COVID-19 mild to moderate
Male and nonpregnant femalepatients at 18 years of age or older were eligible after they were confirmedas SARS-CoV-2 positive by RT-PCR. In addition, patients wereincluded if their peripheral capillary oxygen saturation (SpO2) was >94% on room air at screening. Symptoms of infection include fever,cough, and myalgia, with diarrhea, with the subsequent developmentof dyspnea or of pneumonia on chest CT. Patients with moderatepneumonia were then included following Diagnosis and TreatmentProtocol for Novel Coronavirus Pneumonia
Open-label.
Single center, Shanghai Public Health Clinical Center, Shanghai, China.
ivermectin (n=57) vs. placebo (n=58)
randomized controlled trial
Ivermectin
ivermectin 12 mg on day 1 and day 2
Placebo
COVID-19 mild to moderate
All patients above the age of 18 admitted with a diagnosis of COVID -19 (on the basis of a positive RT PCR or Rapid Antigen Test report) at AIIMS, Patna, India with mild or moderate disease as defined by the ministry of health and family welfare guidelines and not meeting any of the exclusion criteria were considered eligible for the study. The exclusion criteria were: known allergy to or adverse drug reaction with Ivermectin; unwillingness or inability to provide consent to participate in the study; prior use of ivermectin during the course of this illness; pregnancy and lactation.
Double-blind.
Single center, tertiary care dedicated COVID-19 hospital in Bihar, India.
ivermectin (n=12) vs. placebo (n=12)
randomized controlled trial
ivermectin
400 mcg/kg, single dose
placebo
COVID-19 mild to moderate
double bliind
1 center, Spain
ivermectin (n=30) vs. standard of care (n=15)
randomized controlled trial
Ivermectin
Standard of care plus oral ivermectin at 0.6 mg/kg/day for 5 days.
Standard of care
All patients in both groups received standard of care.
COVID-19 mild to moderate
Eligibility criteria included COVID-19 symptoms onset ≤ 5 days at recruitment, absence of use of drugs with potentialactivity against SARS-CoV-2 and available in Argentina during the trial (hydroxychloroquine, chloroquine, lopinavir and azithromycin); and those drugs were not permitted during the first week of the trial.
Open-label.
4 hospitals in the metropolitan area of Buenos Aires, Argentina.
ivermectin (n=241) vs. standard of care (n=249)
randomized controlled trial
oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care
standard of care alone
symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging.
COVID-19 mild to moderate
open-label
Malaysia
ivermectin (n=35) vs. standard of care (n=38)
randomized controlled trial
Ivermectin
Single dose of 0.2 mg/kg
Standard of care
Standard drugs of the national protocol are used.
All patients in both groups received supportive medical treatment for COVID-19 according to the national protocols of Iran at the time of this study (hydroxychloroquine and/or lopinavir/ritonavir).
COVID-19 mild to moderate
The diagnostic criteria for COVID-19 included any of the following: (1) positive result on COVID-19 reverse-transcription polymerase chain reaction; (2) clinical symptoms of COVID-19, with a history of contact with a patient with COVID-19; and/or (3) abnormalities on chest computed tomography (CT) compatible with COVID19 (ground-glass opacity, halo sign, reversed halo sign, and patchy infiltration).
Double-blind.
2 centers in Mazandaran, Iran.
Clinical improvement after baseline was defined as resolving a patient’s baseline status on persistent and continuous cough (persistent cough for >1 hour, or ≥3 coughing episodes in 24 hours, that interferes with activities of daily living and the ability to work) and tachypnea in addition to increasing oxygen saturation to >94%.
ivermectin plus doxycycline (n=200) vs. standard of care (n=200)
randomized controlled trial
Ivermectin and Doxycycline
Ivermectin 6 mg, 2 tab stat and Doxycycline 100 mg twice daily for 5 days
standard of care
COVID-19 mild to moderate
double blind
1 center, Bangladesh
lenzilumab (n=261) vs. placebo (n=259)
randomized controlled trial
Lenzilumab
Standard of care plus three intravenous doses of lenzilumab (600 mg per dose) delivered 8h apart. Infusions beginning at day 0 within 12h of randomisation.
Placebo
Standard of care plus three doses of 0.9% saline for injection delivered 8h apart.
All patients received standard supportive care, including the use of remdesivir and corticosteroids. Paracetamol 500–1000 mg orally or intravenously and diphenhydramine 12.5–25 mg intravenously or 25 mg orally (or equivalent) were administered approximately 1h before lenzilumab or placebo infusion to prevent hypersensitivity reactions.
COVID-19 mild to moderate
At least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation (NIPPV); and were hospitalized but did not require IMV. Patients were excluded if they required IMV or extracorporeal membrane oxygenation (ECMO).
Double-blind.
29 sites in the US and Brazil.
For the purposes of the survival analysis for the primary endpoint, an event was defined as mortality or the requirement for IMV.
lopinavir/ritonavir (n=21) vs. standard of care (n=7)
randomized controlled trial
Lopinavir-ritonavir
Lopinavir (200mg) boosted by ritonavir (50mg) (oral, q12h, 500 mg each time for 7-14 days) monotherapy
Standard of care.
No antiviral medication. Supportive care and effective oxygen therapy if in need.
3 arms: lopinavir/ritonavir (n=21), arbidol=umifénovir (n=16) and standard of care (n=7).Standard of care in both groups.
COVID-19 mild to moderate
Open-label
China, single center
lopinavir/ritonavir, ribavirin and interferon beta-1b (n=86) vs. lopinavir/ritonavir (n=41)
randomized controlled trial
Interferon beta-1b, lopinavir–ritonavir, and ribavirin
14-day combination of lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin 400 mg every 12 h, and three doses of 8 million international units of interferon beta-1b on alternate days
lopinavir–ritonavir
14 days of lopinavir 400 mg and ritonavir 100 mg every 12 h
COVID-19 mild to moderate
age at least 18 years, a national early warning score 2 (NEWS2) of at least 1, and symptom duration of 14 days or less upon recruitment
Open-label.
Hong Kong, 6 centers
phase 2, intention-to-treat population
there is a discrepancy between the main objective of the study mentioned in clinicaltrials.gov which refers to mortality and the main endpoint presented in the publication. The sample size calculation also refers to mortality. However, at the date of initial registration (Feb. 19), the primary endpoint was already PCR-negative conversion, which allows to rule out result-driven change.
peginterferon (n=60) vs. placebo (n=60)
randomized controlled trial
Peginterferon Lambda-1a
Peginterferon Lambda-1a (180 mcg subcutaneous injection) single dose alone with standard of care.
Placebo
Normal saline placebo subcutaneous injection along with standard of care Treatment for COVID-19 Infection.
COVID-19 mild to moderate
Age ≥ 18 years and ≤ 75 years at the time of the assessmentAble and willing to understand the study, adhere to all study procedures, and provide written informed consentDiagnosis of COVID-19 disease:If symptomatic, the presence of mild to moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours from swab to the time of commencing informed consent:If asymptomatic, initial diagnosis of SARS-CoV-2 infection with positive FDA-cleared molecular diagnostic assay obtained no more than 72 hours from initial swab to the time of commencing informed consent
Open-label.
Single-blind.
Phase II. Single-blind study in which only patients are blinded.
pegylated interferon-α2b (n=20) vs. standard of care (n=20)
randomized controlled trial
Single dose of PEG IFN-α2b
PEG IFN-α2b; 1 mg/kg subcutaneous injection, single dose, plus SOC.
Standard of care
SOC alone.
Antipyretics, cough suppressants, antibiotics, steroids, vitamins, anticoagulants, and hydroxychloroquine were administered as per regulatory recommendation and approval.
COVID-19 mild to moderate
1. Ability to comprehend and willingness to sign a written ICF for the study 2. Male or non-pregnant females, >= 18 years of age at the time of enrolment 3. Understands and agrees to comply with planned study procedures 4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen 6.Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).
Open-label.
Multicenter, six study centers in India.
The primary efficacy endpoint was clinical status assessed onday 15 on a WHO 7-point ordinal scale consisting of the following categories: 1, not hospitalized, no limitations of activities; 2, not hospitalized, limitation on activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, on non-invasive ventilation or high flow oxygen devices; 6, hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and 7, death.
Phase II. All patients were hospitalized.
pegylated interferon-α2b (n=120) vs. standard of care (n=130)
randomized controlled trial
Pegylated interferon-α2b
Standard of care plus a single dose of PEG IFN-α2b.
Standard of care
SOC treatments [i.e. antipyretics, cough suppressants, antibiotics, steroids, vitamins, anticoagulants, hydroxychloroquine and antivirals (e.g. remdesivir)] were administered as per the COVID-19 clinical management guidelines of the Ministry of Health, Government of India and the practices of the individual institutions.
COVID-19 mild to moderate
age ≥18 years, RT-PCR-confirmed SARS-CoV-2 infection, pneumonia with no signs of severe disease, respiratory rate ≥24 breaths/min, SpO2 90–94%, and a negative pregnancy test (for female patients of child-bearing potential).
Open-label.
Multicenter; 20 study centers across India.
The scale consists of the following categories: 1, not hospitalized, no limitation of activities; 2, not hospitalized, limitation of activities; 3, hospitalized, does not require supplemental oxygen; 4, hospitalized, requires supplemental oxygen; 5, hospitalized, requires noninvasive ventilation or on high flow oxygen devices; 6, hospitalized, requires invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and 7, death.
progesterone (n=20) vs. standard of care (n=22)
randomized controlled trial
subcutaneous progesterone
progesterone (100 mg subcutaneously twice daily for up to 5 days) plus SOC
SOC alone
COVID-19 mild to moderate
open-label
Cedars Sinai Medical Center, Los Angeles, USA
remdesivir (n=200) vs. remdesivir (n=197)
randomized controlled trial
Remdesivir (5 days)
Intravenous remdesivir 200 mg on day 1, followed by 100 mg of remdesivir once daily for the subsequent 4 days.
Remdesivir (10 days)
Intravenous remdesivir 200 mg on day 1, followed by 100 mg of remdesivir once daily for the subsequent 9 days.
Both treatment groups continued supportive therapy at the discretion of the investigator throughout the duration of the trial.
COVID-19 mild to moderate
Patients who were receiving mechanical ventilation and extracorporeal membrane oxygenation (ECMO) at screening were excluded, as were patients with signs of multiorgan failure.
Open-label.
55 hospitals in the United States, Italy, Spain, Germany, Hong Kong, Singapore, South Korea, Taiwan.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, receiving invasive mechanical ventilation or ECMO; 3, hospitalized, receiving noninvasive ventilation or high-flow oxygen devices; 4, hospitalized, requiring low-flow supplementaloxygen; 5, hospitalized, not requiring supplemental oxygen but receiving ongoing medical care (related or not related to Covid-19); 6, hospitalized, requiring neither supplemental oxygen nor ongoing medical care (other than that specified in the protocol for remdesivir administration); and 7, not hospitalized.
remdesivir (n=199) vs. standard of care (n=200)
randomized controlled trial
5-day course of remdesivir
200 mg of remdesivir intravenously on day 1, followed by 100 mg of remdesivir once daily for the subsequent days, infused over 30 to 60 minutes.
Standard care
Treatment with SOC according to local practice.
3 arms study : RDV 5 days, RDV 10 days, standard of care. All participants will continue to receive SOC therapy according to local guidelines. Participants randomized to receive RDV will receive thisin addition to their other care. Remdesivir treatment was to be discontinued in any patient experiencing severe elevations in liver enzymes or decreases in estimated creatinine clearance to less than 30 mL/min.
COVID-19 mild to moderate
Participants with COVID-19 confirmed by polymerase chain reaction (PCR) who meet the following criteria: Willing and able to provide written informed consent (age ≥18) or assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures, Hospitalized and requiring medical care for COVID-19, SpO2 > 94% on room air at screening, Radiographic evidence of pulmonary infiltrates.
Open-label.
Multicenter: 105 hospitals in the United States, Europe, and Asia.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation; 3, hospitalized, requiringnoninvasive ventilation or use of high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related or not to COVID-19); 6, hospitalized, not requiring supplemental oxygen orongoing medical care; and 7, not hospitalized. Differences between remdesivir treatment groups and standard care were calculated usingproportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicatesdifference in clinical status distribution toward category 7 for the remdesivir group vs thestandard care group.
remdesivir (n=197) vs. standard of care (n=200)
randomized controlled trial
Remdesivir (10 days)
200 mg of remdesivir intravenously on day 1, followed by 100 mg of remdesivir once daily for the 9 subsequent days, infused over 30 to 60 minutes.
Standard of care
Treatment with SOC according to local practice.
3 arms study : RDV 5 days, RDV 10 days, standard of care. All participants will continue to receive SOC therapy according to local guidelines. Participants randomized to receive RDV will receive thisin addition to their other care. Remdesivir treatment was to be discontinued in any patient experiencing severe elevations in liver enzymes or decreases in estimated creatinine clearance to less than 30 mL/min.
COVID-19 mild to moderate
Participants with COVID-19 confirmed by polymerase chain reaction (PCR) who meet the following criteria: Willing and able to provide written informed consent (age ≥18) or assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures, Hospitalized and requiring medical care for COVID-19, SpO2 > 94% on room air at screening, Radiographic evidence of pulmonary infiltrates.
Open-label.
Multicenter: 105 hospitals in the United States, Europe, and Asia.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation; 3, hospitalized, requiringnoninvasive ventilation or use of high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related or not to COVID-19); 6, hospitalized, not requiring supplemental oxygen orongoing medical care; and 7, not hospitalized. Differences between remdesivir treatment groups and standard care were calculated usingproportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicatesdifference in clinical status distribution toward category 7 for the remdesivir group vs thestandard care group.
sabizabulin (n=134) vs. placebo (n=70)
randomized controlled trial
daily oral doses of sabizabulin 9mg for 21 days
placebo
COVID-19 mild to moderate
double-blind
27 centers, worldwide
met the prespecified superiority criterion for efficacy at the time of the interim analysis with 150 patients
planned interim analysis
sofosbuvir and ledipasvir (n=45) vs. standard of care (n=45)
randomized controlled trial
Sofosbuvir/ledipasvir
SOF/LDP 400/90 mg daily for 10 days plus standard of care.
Standard of care
Standard of care alone.
In addition to the supportive care modalities, the standard of care according to the hospital protocol included hydroxychloroquine (HCQ 400 mg BD at first day then 200 mg BD for 7 days) plus atazanavir/ritonavir 300/100 mg daily for 7 days. Standard of care in both groups.
COVID-19 mild to moderate
Adult patients (≥18 years old) with highly suspected (according to the clinical signs/symptoms andimaging findings) or confirmed (a positive PCR of pharyngeal or nasopharyngeal samples) COVID-19 who were admitted to medical wards of the hospital, were included.
Open-label.
Single-center, Imam Khomeini Hospital Complex, Tehran, Iran.
Clinical response was defined as one order decline in disease category in the five category ordinal scale. The categories are: death (5), mechanical ventilation (4), non-invasive ventilation (3), oxygen mask or nasal cannula (2), discharge(1).
umifenovir (arbidol) (n=35) vs. lopinavir/ritonavir (n=34)
randomized controlled trial
Umifenovir
Arbidol (100mg) (oral, 200mg TID for 7-14 days)
Lopinavir/ritonavir
Lopinavir (200mg) boosted by ritonavir (50mg) (orally administed, twice daily, 500 mg, each time for 7-14 days).
3 arms : lopinavir/ritonavir; arbidol and standard care
COVID-19 mild to moderate
Open-label
China, single center
No deaths occurred.
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