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colchicine (n=50) vs. placebo (n=50)
randomized controlled trial
Colchicine
1 mg tablet of colchicine daily alongside the Hydroxychloroquine for 6 days.
Placebo
Similar tablet without therapeutic effects alongside the Hydroxychloroquine for 6 days.
HCQ in both groups.
COVID 19 hospitalized
Unclear
Single center, Imam Reza hospital in Ardabil city, Iran.
Blindness unclear: Prospective, open-label, randomized and double blind clinical trial. The participants of the placebo group were received a similar tablet without therapeutic effects.
None of the patients died or were readmitted.
colchicine (n=55) vs. standard of care (n=50)
randomized controlled trial
Colchicine
1.5-mg loading dose followed by 0.5 mg after 60 min (in the case of azithromycin coadministration, a single 1.0-mg loading dose of colchicine was administered) and maintenance doses of 0.5 mg twice daily for as long as 3 weeks. Surveillance of gastrointestinal effects after the loading dose.
Standard treatment
Local protocols
Standard of care in both groups.
COVID 19 hospitalized
Patients >18 years old with laboratory confirmed SARS-CoV-2 infection (RT PCR) AND body temperature >37.5 degrees centigrade AND at least two of: i. sustained coughing, ii. sustained throat pain, iii. anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2<95 mmHg, were considered eligible.Patients with clinical assessment indicating that ventilatory support would be inevitable in the following 24 hours because of rapidly declining respiratory status were excluded.
Open-label.
16 tertiary care hospitals in Greece.
Study end point analysis was planned to be performed in 2 phases, an early biochemical phase and a later clinical phase. The 7-grade ordinal scale consisted of the following levels: 1, ambulatory, normal activities; 2, ambulatory but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both; and 7, death.
primary endpoints of low clinical relevence
colchicine (n=5610) vs. standard of care (n=5730)
randomized controlled trial
colchicine twice daily for 10 days or until discharge plus usual standard of care
usual standard of care alone
COVID 19 hospitalized
open-label
UK
colchicine (n=5610) vs. standard of care (n=5730)
randomized controlled trial
Colchicine
Usual care plus colchicine 1 mg after randomisation followed by 500 µg 12 h later and then 500 µg twice a day by mouth or nasogastric tube for 10 days in total or until discharge.
Usual care
94% of patients were being treated with a corticosteroid. As a platform trial, and in a factorial design, patients could be simultaneously randomly assigned to other treatment groups: 1) convalescent plasma versus casirivimab and imdevimab versus usual care, 2) aspirin versus usual care, and 3) baricitinib versus usual care. Until Jan 24, 2021, the trial also allowed a subsequent randomisation for patients with progressive COVID-19 (evidence of hypoxia and a hyperinflammatory state) to receive usual care plus tocilizumab or usual care alone.
COVID 19 hospitalized
Patients admitted to hospital were eligible for the study if they had clinically suspected or laboratory confirmed SARS-CoV-2 infection and no medical history that might, in the opinion of the attending clinician, put the patient at significant risk if they were to participate in the trial. Children and pregnant women were not eligible to receive colchicine.
Open-label.
177 hospitals in the UK, 2 hospitals in Indonesia, 2 hospitals in Nepal.
colchicine (n=640) vs. standard of care (n=639)
randomized controlled trial
Colchicine
Usual care plus colchicine administered orally in a loading dose of 1.5mg immediately after randomization, followed by 0.5mg orally within 2 hours of the initial dose and 0.5mg orally twice a day for 14 days or discharge, whichever occurred first.
Usual care
local standard of care for COVID-19 SARS moderate /high-risk patients
COVID 19 hospitalized
Consented adults (age ≥18 years)COVID-19 suspicious andadmitted to hospital or already in hospital and fever (with or without at the time of randomization) andSARS (severe acute respiratory syndrome)-shortness of breath (dyspnea) or-image of typical or atypical pneumonia or-oxygen desaturation (spO2 ≤ 93)
Open-label.
42 centers in Argentina.
The original trial protocol included in-hospital mortality as the primary outcome and the composite of a new requirement for mechanical ventilation or death as a key secondaryoutcome. Due to low recruitment rate and low likelihood of reaching the original estimated sample size of 2500 patients, the executive committee decided to change the primary outcome in November 2020 prior to knowing the results to include 2 coprimary hierarchical outcomes with the aim of reducing the trial sample size and potentially getting an earlier result.
Colchicine plus rosuvastatin (n=161) vs. standard of care (n=162)
randomized controlled trial
Colchicine plus rosuvastatin
Standard of care
The standard of care follows the recommendations of the Colombian Consensus forCovid-19 Treatment in Hospitalized Patients,21 consisting of the use of dexamethasone,antiparasitic treatment (ivermectin or albendazole), enoxaparin, acetaminophen, oxygen asneeded, and supportive treatment for organ failure (i.e., use mechanical ventilation, ordialysis).
COVID 19 hospitalized
Adults aged 18 years or more, with a positive real-time polymerase chain reaction (RT-PCR) or with high suspicion of SARS CoV-2 by clinical criteria and a diagnosis of mild, severe, or critical pneumonia, requiring hospital management in six high complexity referral hospitals located in Bogota.
Open-label.
6 hospitals in Bogota, Colombia.
Relative Risks adjusted for age, sex, and severity of pneumonia using g Log-binomial General Estimating Equation models, assuming exchangeable correlation structure with each center as a cluster.
mavrilimumab (n=21) vs. placebo (n=19)
randomized controlled trial
Mavrilimumab
Single intravenous infusion of Mavrilimumab 6mg/kg
Placebo
Concomitant medications included antiviral drugs relatedto COVID-19, corticosteroids, convalescent plasma, otherimmunosuppressive agents, and antimicrobial drugsrelated to non-COVID-19 infections.
COVID 19 hospitalized
Patients with documented COVID19 pneumonia defined as positive SARS-CoV2 test AND abnormalities/infiltrates on chest x-ray or computed tomography AND active fever or documented fever within 24-48 hours or ongoing anti-pyretic use to suppress fever, hypoxia (Room air SpO2 <92% or requirement for supplemental oxygen), increased serum inflammatory marker (CRP > 5 mg/dL), severity of disease warrants inpatient hospitalization. Patients were excluded if they required mechanical ventilation.
Double-blind.
Multicenter, 7 hospitals in United States.
A trial of 60 patients was planned, but given slow enrolment, the study was stopped early toinform the natural history and potential treatment effect.
stem cells (n=12) vs. placebo (n=12)
randomized controlled trial
Umbilical cord mesenchymal stem cell (UC-MSC)
Two intravenous infusions of 100 ± 20 × 106 UC-MSCs each, in 50 mL vehicle solution containing human serum albumin and heparin, infused over10 ± 5 minutes, at days 0 and 3.
Placebo
Two infusions of 50 mL vehicle solution, at day 0 and day 3.
Best standard of care was provided in both groups following the current institutional COVID-19 guidelines.
COVID 19 hospitalized
Patient hospitalized; age ≥ 18 years; peripheral capillary oxygen saturation (SpO2) ≤ 94% at room 134air, or requiring supplemental oxygen at screening; PaO2/FiO2 ratio < 300 mmHg; and bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan.
Double-blind.
Single-center, UHealth System/Jackson Health System (UHS/JHS), in Miami, Florida, United-States.
Phase 1/2a.
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
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.
stem cells (n=66) vs. placebo (n=35)
randomized controlled trial
Human umbilical cord mesenchymal stem cells (UC-MSCs)
UC-MSCs (4 × 107 cells per infusion) on day 0, 3 and 6.
Placebo
Saline containing 1% Human serum albumin (solution without UC-MSCs). Infusion on day 0, 3, 6.
2:1 ratio. All patients received standard of care.
COVID-19 severe or critically
Hospitalized patients with severe COVID-19 with laboratory-confirmed SARS-CoV-2 infection by reverse transcription polymerase chain reaction (RT-PCR) with severe COVID-19 diagnosed after onset of disease; or chest computed tomography (CT) imaging confirmed pneumonia combined with lung damage. Patients with shock or COVID-19 combined with any one of other organ failures or who received invasive ventilation were excluded.
Double-blind.
Wuhan, China.
Phase II.
stem cells (n=12) vs. standard of care (n=29)
randomized controlled trial
Umbilical cord mesenchymal stem cell infusion (hUC-MSCs)
Umbilical cord mesenchymal stem cell intravenous infusion plus standard of care. Before the intravenous drip, the MSCs were suspended in 100 ml of normal saline, and the total number of transplanted cells was calculated as 2 × 106 cells/kg. The infusion was from the patients’ right cubital veins and lasted approximately 1 h (35 drops/min).
Standard treatment
Supplemental oxygen (noninvasive or invasive ventilation); antiviral agents (abidor/oseltamivir); antibiotic agents (moxifloxacin is taken orally; if there is clear evidence of bacteriological infection, the choice of antibacterial drugs is based on a drug sensitivity test), and glucocorticoid therapy (1-2 mg/kg, less than a week).
Standard treatments in both groups.
COVID-19 severe or critically
Criteria for severe disease are A) an epidemiological history; B) etiological evidence (i.e., a positive SARS-CoV-2 nucleic acid test by the real time reverse transcription polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 RNA from the Chinese Center for Disease Control and Prevention); AND C) CT imaging indicators of pneumonia. In addition, these factors should coincide with any of the following criteria: (a) respiratory distress, respiration rate (RR) ≥ 30 times/min; (b) oxygen saturation ≤93% in the resting state; and (c) PaO2/FiO2 ≤ 300 mmHg (1 mmHg = 0.133 kPa).
Open-label.
Single-center, Huangshi Hospital of Traditional Chinese Medicine in Hubei Province, China.
NEWS2 score and seven category ordinal scale were used to assess the clinical symptoms and conditions of the enrolled patients.
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