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bamlanivimab monotherapy (n=101) vs. placebo (n=156)
randomized controlled trial
Bamlanivimab (LY-CoV555) 700 mg
placebo
5 arms: placebo, bamlanivimab 700 mg, 2800 mg, and 7000 mg and 2800 mg of bamlanivimab and 2800 mg of etesevimab
COVID 19 outpatients
double-blind
Phase 2: exploratory trial, originally designed as a safety and biomarker study. Inconclusive for the primary endpoint.
As of April 2021, regulatory authorities recommend that bamlanivumab no longer be used because of the potential risk of treatment failure due to the circulation of resistant variants of SARS-CoV-2.
bamlanivimab/etesevimab (n=112) vs. placebo (n=156)
randomized controlled trial
bamlanivimab 2800 mg and etesevimab 2800 mg
placebo
5 arms: placebo, bamlanivimab 700 mg, 2800 mg, and 7000 mg and 2800 mg of bamlanivimab and 2800 mg of etesevimab
COVID 19 outpatients
double-blind
Phase 2. Exploratory trial, originally designed as a safety and biomarker study.
October, 2021 EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. Janvier, 2022: FDA limit the use of bamlanivimab and etesevimab to infection due to susceptible variants (ie not omicron).
bamlanivimab/etesevimab (n=518) vs. placebo (n=517)
randomized controlled trial
bamlanivimab 2,800 mg plus etesevimab 2,800 mg
single intravenous (IV) infusion within 3 days of having a positive result on a SARS-CoV-2 virologic test
placebo
COVID 19 outpatients
Participants were excluded if they had a saturation of oxygen (SpO2) ≤93% on room air, respiratory rate ≥30 breaths/min, or heart rate ≥125 bpm
double-blind
October, 2021 EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. Janvier, 2022: FDA limit the use of bamlanivimab and etesevimab to infection due to susceptible variants (ie not omicron).
casirivimab/imdevimab (Ronapreve) (n=156) vs. placebo (n=158)
randomized controlled trial
Casirivimab 600 mg and imdevimab 600 mg
Single 1200 mg dose.
Placebo
Placebo at day 1 via subcutaneous injection.
COVID 19 outpatients
Double-blind.
112 sites in the US, Romania and Moldova.
The trial consists of a 1-day screening/baseline period, a 28-day efficacy assessment period (EAP), and a 7-month follow-up period.
*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.*
casirivimab/imdevimab (Ronapreve) (n=838) vs. placebo (n=840)
randomized controlled trial
REGEN-CO 1200mg (casirivimab and imdevimab) IV
Placebo
3 arms: placebo, REGEN-COV 2400mg (1200mg each antibody) and REGEN-COV 1200mg (600mg each antibody). (8,000 mg data were converted to a descriptive analysis)
COVID 19 outpatients
Patients ≥18 years of age and non-hospitalized, with a confirmed local SARS-CoV-2-positive diagnostic test result ≤72 hours and onset of any Covid-19 symptom, as determined by the investigator, ≤7 days before randomization, maintain O2 saturation ≥93% breathing room air, not have prior or current use of putative COVID-19 treatments (e.g. convalescent plasma, systemic corticosteroids or remdesivir) and not have been previously or currently hospitalized for treatment of COVID-19.
Double-blind.
Analysis in modified full analysis set (subjects with positive RT-qPCR test at baseline).The primary and two key secondary endpoints were tested hierarchically. The key secondary clinical endpoints were (1) the proportion of patients with ≥1 Covid-19-related hospitalization or all-cause death from day 4 through day 29 and (2) the time to Covid-19 symptoms resolution (19 of the 23 recorded symptoms).
*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.*
convalescent plasma treatment (n=207) vs. placebo (n=209)
randomized controlled trial
convalescent plasma
placebo
regular plasma
COVID 19 outpatients
double blind
netherlands
phase 3. Based on the recommendation by the DSMB (rapid uptake of vaccination and effective monoclonal antibodies available for high risk outpatients), the study was terminated on the 13th of July 2021 before the planned sample size of 690 was reached
convalescent plasma treatment (n=257) vs. placebo (n=254)
randomized controlled trial
COVID-19 convalescent plasma
One unit (250 mL) of ABO-compatible COVID-19 convalescent plasma.
Placebo
250 mL of normal saline (colored with a parenteral multivitamin concentrate to resemble plasma).
COVID 19 outpatients
=< 18 years with one or more symptoms of COVID-19 illness and laboratory-confirmed SARS-Cov-2 infection, at least one study defined risk factor for severe COVID-19 illness, clinical team deems stable for outpatient management without supplemental oxygen, CP available at the site at the time of enrollment, duration of symptoms =< 7 days at ED presentation, informed consent from subject.
Single-blind.
Multicenter: 48 hospital emergency departments across the United States.
Trial enrollment was halted after the second planned interim analysis of the primary outcome indicated that the a priori stopping threshold for futility had been reached on the basis of a posterior predictive probability of success of 0.042.
convalescent plasma treatment (n=188) vs. placebo (n=160)
randomized controlled trial
convalescent plasma
anti-SARS-CoV-2 MBT plasma plus SMT will undergo an ABO compatibility test and will receive a single infusion of 200 to 300 ml
placebo
200 to 300ml of sterile saline solution 0.9%.
COVID 19 outpatients
double blind
4 centers, Spain
The trial was stopped early following a data safety monitoring board recommendation because more than 85% of the target population had received a COVID-19 vaccin
peginterferon (n=30) vs. placebo (n=30)
randomized controlled trial
Peginterferon lambda-1a
Single 180 µg subcutaneous injection of peginterferon lambda within 7 days ofsymptom onset or first positive swab if asymptomatic.
Placebo
Single 180 µg subcutaneous injection of saline placebo within 7 days ofsymptom onset or first positive swab if asymptomatic.
COVID 19 outpatients
Adult patients between the ages of 18 and 70 years, confirmed COVID-19 infection by PCR within 5 days of symptom onset (fever, respiratory symptoms, sore throat), and discharged to home isolation.
Double-blind.
Multicenter, 6 institutions in Toronto, Canada.
Because of non identical matching placebo, one of two study personnel administering the medication was aware of the treatmentallocation. After administering the medication, all further follow-up (phone calls and study visits) was completed by study personnel unaware of treatment allocation.
Type III Interferon.
sotrovimab (Xevudy; VIR-7831) (n=528) vs. placebo (n=529)
randomized controlled trial
Sotrovimab (VIR-7831, GSK4182136) as monotherapy
Intravenous infusion of sotrovimab 500 mg over 1 hour on day 1.
Placebo
Equal volume of saline placebo over 1 hour on day 1.
Patients were observed for approximately 2 hours after infusion.
COVID 19 outpatients
18 years of age and older with at least one of the following comorbidities: diabetes, obesity (BMI >30), chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, or moderate to severe asthma, or were 55 years of age and older regardless of comorbidities. Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms
Double-blind.
57 centers in 5 countries: US, Brazil, Spain, Canada, Peru.
*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.* data reported in FDA emergency use authorization (EUA), results from interim analysis.
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