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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).
budesonide (n=1073) vs. standard of care (n=1988)
randomized controlled trial
inhaled budesonide (800μg twice daily for 14 days) plus usual care
Inhaled budesonide (800μg twice daily for 14 days) plus usual care;
usual care
several arms: usual care, usual care plus budesonide or usual care plus other interventions
COVID 19 outpatients
Open-label.
United Kingdom.
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.*
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.*
ciclesonide (n=108) vs. placebo (n=107)
randomized controlled trial
Ciclesonide
Inhaled ciclesonide (600 μg twice daily) along with the usual dose of intranasal ciclesonide (200 μg daily) for 14 days.
Placebo
Saline placebo metered dose inhaler and intranasal saline of a similar appearance to ciclesonide at the same dosing schedule.
COVID 19 outpatients
Adults aged 18 years and older who had polymerase chain reaction confirmed COVID-19 at enrolment with at least one of the symptoms of fever, cough (wet or dry), or shortness of breath (including dyspnoea, chest congestion, or chest tightness as synonyms). People were excluded if they were admitted to hospital, had only non-respiratory symptoms (eg, nasal congestion, myalgias, or gastrointestinal symptoms), had already been prescribed an inhaled steroid.
Double-blind.
Three Canadian provinces (Quebec, Ontario, and British Columbia).
Enrolment to the trial began on 15 September 2020 in Quebec, 9 February 2021 in Ontario, and 22 March 2021 in British Columbia. The last participants were recruited on 8 June 2021. Participants self-reported outcome data for the 14 days after enrolment, including improvement in covid-19 related respiratory symptoms, other covid-19 symptoms, adherence to the trial intervention, side effects, and hospital admissions.
ciclesonide (n=197) vs. placebo (n=203)
randomized controlled trial
Ciclesonide pressurised metered-dose inhaler (pMDI).
Supportive care plus ciclesonide (Alversco) 320 mcg twice daily for 30 days via pMDI.
Placebo
Supportive care plus placebo mztching Alvesco, twice daily for 30 days via pMDI.
Standard supportive care was provided at the discretion of the study nurse or physician and included recommendations for symptomatic medications and directions to seek emergency care when necessary.
COVID 19 outpatients
Double-blind.
Multicenter; 10 centers throughout the US (public and private, academic and non-academic sites).
Time to alleviation of COVID-19-related symptoms of cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell, defined as symptom-free for a continuous period of more than 24 hours (ie, later than 3 AM/PM assessments) by day 30.
Changes in primary outcome during the trial: A primary outcome based on symptom resolution was chosen rather than one based on emergency department visits or hospital admission after preliminary data demonstrated substantially lower than expected rates of emergency department visits or hospitalizations among study participants.
colchicine (n=2235) vs. placebo (n=2253)
randomized controlled trial
Colchicine
Colchicine 0.5 mg per os twice daily for the first 3 days, then once daily for the last 27 days.
Placebo
Placebo per os twice daily for the first 3 days, then once daily for the last 27 days.
COVID 19 outpatients
adults >= 40 years old diagnosed with COVID19 within the last 24h; not currently hospitalized and not under immediate consideration for hospitalization. Patients must possess at least one high-risk criteria (>70 years old, diabetes mellitus, uncontrolled hypertension, respiratory disease, heart failure, coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count).
Double blind, randomized.
Brazil, Canada, Greece, South Africa, Spain, and the USA
multiple testing
premature discontinuation due to logistical issues
colchicine (n=212) vs. standard of care (n=2081)
randomized controlled trial
Colchicine
Usual care plus colchicine 500µg daily for 14 days.
Usual care
COVID 19 outpatients
Open-label.
Participants were followed up through an online, daily symptom diary for 28 days after randomisation, supplemented with telephone calls to non-responders on days 7, 14 and 28. The diary includes questions about illness recovery (ascertained by answering the question, “Do you feel recovered today? (i.e. symptoms associated with illness are no longer a problem) Yes/No”), overall illness severity (a rating of how well they are feeling on a scale of 1-10 [1 being the worst and 10 being the best]), individual symptom severity on a four-point scale (0 = no problem to 3 =major problem), and healthcare service utilisation.
Trial stopped for futility on May 26, 2021.
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
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
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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