Table 1.

List of clinical trials assessing safety and efficacy of Molnupiravir for treatment of COVID-19.

Rank	ID number	Title	Status	Phase	Size	Interventions	Study design
Clinical trials.gov (N = 6)
1	NCT04575584/Other Study identifier on Cochrane (JRCT2031200404)	Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482–001)	Terminated	Phase 2/Phase 3	1300	Drug: Molnupiravir administered orally in capsule form every 12 h for 5 days (10 doses total) Placebo matching Molnupiravir administered orally in capsule form every 12 h for 5 days (10 doses total)	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
2	NCT04575597/Other Study Identifier on Cochrane (JRCT2031210148)	(MOVe-OUT) Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)	Completed	Phase 2/Phase 3	1850	Drug: Molnupiravir | Drug: Placebo	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
3	NCT04939428	(MOVe-AHEAD) Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)	Recruiting	Phase 3	1332	Drug: Molnupiravir/|Drug: Placebo	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Prevention
4	NCT04405739	The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID)	Recruiting	Phase 2	96	Drug: EIDD-2801/Drug: Placebo	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator Primary Purpose: Treatment
5	NCT04405570/Other identifier on PubMed (PMID: 35022711)	A Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19	Completed	Phase 2a	204	•Initially, participants were randomized in a 1:1 ratio to receive 200 mg molnupiravir or placebo twice daily for 5 days. Subsequently, in the dose-range finding portion of the study, participants were randomized in a 3:1 ratio to receive 200, 400, or 800 mg molnupiravir or placebo twice daily for 5 days.	•Allocation: Randomized Intervention Model: Cross-Sectional Masking: Double blinded (Participant, Investigator) Primary Purpose: Treatment
6	NCT04746183/Other identifier on Cochrane (EUCTR2020-001860-27)	AGILE (Early Phase Platform Trial for COVID-19)/AGILE: seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment. A randomized Phase I/II study to determine the safety and effectiveness of multiple drugs for the treatment of COVID-19	Recruiting	Phase 1|Phase 2	600	Drug: CST-2: EIDD-2801|Drug: CST-2: Placebo| Drug: Nitazoxanide| Drug: VIR-7832|Drug: VIR-7831|Drug: CST-5: Placebo INTERVENTION: Phase I – Patients randomized to EIDD-2801 or standard of care (SOC). EIDD-2801 administered orally, twice daily (BID) for 10 doses (5 or 6 days). Phase II – Patients randomized to EIDD-2801 and SOC or Placebo and SOC. EIDD-2801 or placebo administered orally, twice daily (BID) for 10 doses (5 or 6 days). Dose of EIDD-2801 will be determined by the recommended dose from Phase I. Patients randomized 1:1 between EIDD-2801 and placebo using permuted block randomization stratified by site	•Allocation: Randomized Intervention Model: Sequential Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Clinical Trials Registry of India (CTRI) (N = 12)
7	CTRI/2021/05/033693	A prospective, randomized, parallel, multicentric, phase-III clinical trial of Molnupiravir 800 mg capsules and standard of care (SOC) compared to standard of care only in confirmed RT-PCR positive patients with mild COVID-19.	Recruiting	Phase 3	1218	•Molnupiravir 200 mg capsules, (4 × 200 mg), twice a day for 5 days before food intake Standard of Care (Ivermectin 12 mg, oral tablet, once daily for 5 days after food intake. Symptomatic medication including anti-pyretic, anti-tussive and multivitamins, Empiric antimicrobial)	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
8	CTRI/2021/05/033739	A Phase III, Multicentric, Prospective, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Molnupiravir in Adult Indian Patients with Mild COVID-19	Not yet recruiting	Phase 3	1218	•Molnupiravir 800 mg (4 capsules of 200 mg) administered orally every 12 h for 5 days AND Standard of Care Comparator Agent: Standard of Care as per the ICMR Clinical Management Protocol	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
9	CTRI/2021/05/033736	A Phase III, Multicentric, Prospective, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Molnupiravir in Adult Indian Patients with Moderate COVID 19	Not yet Recruiting	Phase 2/Phase 3	1282	•Molnupiravir 800 mg (4 capsules of 200 mg) administered orally every 12 h for 5 days (10 doses total) plus Standard of Care. Comparator Agent: Standard of care as per the Clinical Guidance for Management of Adult COVID-19 by ICMR.	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
10	CTRI/2021/05/033904	A Prospective, Randomized, Parallel, Multi-centric, Open label, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Mild Corona virus Disease (COVID-19)	Recruiting	Phase 3	1218	•Molnupiravir: 4 capsules of 200 mg Twice daily for 5 days Comparator Agent: Standard of Care treatment shall be based on the Clinical Guidance for Management of Adult COVID-19 Patients, dated 22 Apr 2021. AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group (Dte. GHS) and recommendations of Ministry of Health and Family Welfare, Government of India.	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
11	CTRI/2021/06/034130 / Same identifier on Cochrane	A Multi-Centric,Prospective, open label, Randomized, Parallel-group, Comparative, Phase III Clinical Trial to evaluate the efficacy and safety of Molnupiravir 800 mg in the treatment of patients diagnosed with mild COVID-19	Recruiting	Phase 3	1218	•4 capsules of Molnupiravir 200 mg each will be given twice a day at interval of 12 h Comparator Agent: Ivermectin, symptomatic medication including oral hydration, anti-pyretic, anti-tussive and multivitamins, Empiric antimicrobials	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
12	CTRI/2021/05/033864	A Prospective, Randomized, Parallel, Multi-centric, Open label, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Moderate Coronavirus Disease (COVID-19)	Recruiting	Phase 3	1282	•Molnupiravir 800 mg (4 capsules of 200 mg) administered orally every 12 h for 5 days AND Standard of Care Comparator Agent: Standard of care as per the Clinical Guidance for Management of Adult COVID-19 by ICMR	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
13	CTRI/2021/06/033938	A Prospective, Randomized, Multicenter, Open Label, Parallel Group Study To Evaluate Safety And Efficacy Of Oral Molnupiravir As Add On To Standard Of Care For Treatment Of Mild Patients With Covid-19 Disease	Recruiting	Phase 3	1218	•Molnupiravir Tablets 200 mg (4 × 200 mg), twice a day for 5 days before food intake Comparator Agent: Standard of Care	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
14	CTRI/2021/06/033992	A prospective, randomized, parallel, multicentric, phase III clinical trial to assess the efficacy and safety of Molnupiravir 800 mg capsules and standard of care (soc) compared to standard of care (soc) only in patients with polymerase chain reaction (RT-PCR) confirmed Mild Covid-19 infection.	Closed Recruitment	Phase 3	1218	•Molnupiravir 800 mg (4x200 mg or 2x400 mg) capsules twice a day (BID) for 5 days plus standard of care (SOC) Comparator Agent:Standard of Care (SOC) only	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: NA
15	CTRI/2021/06/034220	A Multi-Centric, Prospective, open label, Randomized, Parallel-group, Comparative, Phase II/III Clinical Trial to evaluate the efficacy and safety of Molnupiravir 800 mg in the treatment of patients diagnosed with moderate COVID-19.	Recruiting	Phase 2/Phase 3	1282	•Molnupiravir 200 mg capsules, (4 × 200 mg), twice a day,2 capsules of 200 mg each will be given twice a day at interval of 12 h Comparator Agent: Standard care of therapy: Oxygen therapy through non-rebreathing face mask, Anti-inflammatory or immunomodulatory therapy: Inj. Methylprednisolone 0.5 to 1 mg/kg in 2 divided doses (or an equivalent dose of dexamethasone) usually for a duration of 5 to 10 days. Patients may be initiated or switched to oral route if stable and/or improving, Anticoagulation: Conventional dose prophylactic unfractionated heparin or Low Molecular Weight Heparin (weight based e.g., enoxaparin 0.5 mg/kg per day SC) Symptomatic management (oral hydration, anti-pyretics, antitussive, multivitamins),Empiric antimicrobials for co-infections	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
16	CTRI/2021/06/034015	A Multi-Centre, Prospective, Open Label, Parallel, Randomized, Clinical Trial to Assess the Efficacy And Safety Of Molnupiravir 800 Mg Capsules And Standard of Care (SoC) Compared To Standard of Care (SoC) Only In Mild Patients With Polymerase Chain Reaction (PCR) Confirmed COVID-19.	Recruiting	Phase 3	1220	•Molnupiravir 800 mg (4 capsules of 200 mg or 2 capsules of 400 mg) (BID) + Standard of care. Patients will be instructed to take Comparator Agent: The standard of care will be as per physician recommendation or prescription in line to -Revised Guidelines on Clinical Management of COVID-19 by Government of India, Ministry of Health & Family Welfare Directorate General of Health Services, (EMR Division), Version 05, 03rd July 2020.. Treatment may include Oral medications like Ivermectin 12 mg, once daily, anti-pyretic, anti-tussive multivitamins, and antibiotics	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
17	CTRI/2021/07/034588	A Phase 3 Prospective Open Label, Randomized Multicenter Parallel Study to evaluate the efficacy and safety of Molnupiravir capsules when administered along with Standard of Care compared to Standard of Care alone in Indian patients with mild COVID-19 disease	Completed	Phase 3	1220	•Molnupiravir plus standard of care and standard of care alone As per ICMR. Duration of Treatment: 5 days oral twice daily (800 mg) Comparator Agent: Standard of care therapy will be given to the subjects as per the institution practice Duration of Treatment: 5 days	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
18	CTRI/2021/08/035424	A Phase 3 Prospective, Open Label, Randomized, Multicenter, Parallel Study to evaluate the efficacy and safety of Molnupiravir capsules when administered along with Standard of Care compared to Standard of Care alone in Indian patients with Moderate COVID-19 disease	Not Yet Recruiting	Phase 3	100	•Molnupiravir: 5 days treatment with 1600mgs oral twice daily Comparator Agent: Standard of care therapy will be given to the subjects as per the institution practice	•Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open label
Cochrane (N = 3)
19	JPRN-JRCT2031210010	Single and Multiple Dose Study of MK-4482 in Healthy Japanese Adults	Not yet recruiting	Phase I	72	•INTERVENTION: - Drug: MK-4482 (molnupiravir) MK-4482 100–1600 mg administered orally in capsule form once or twice daily (every 12 h for 5.5 days, 11 doses in total) Placebo matching MK-4482 administered orally in capsule form once or twice daily (every 12 h for 5.5 days, 11 doses in total)	Randomized, Placebo-Controlled, Double-Blind
20	NCT04392219	A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of EIDD-2801 Following Oral Administration to Healthy Volunteers	Completed	Phase I	130	Drug: EIDD-2801 Part 1: Subjects will be randomized to receive a single oral dose of EIDD-2801 or Placebo. Part 2: Two single oral doses of EIDD-2801 will be administered to subjects, in an open-label manner. Part 3: Subjects will be randomized to receive twice daily dosing either EIDD-2801 or Placebo. Drug: Placebo Part 1: Subjects will be randomized to receive a single oral dose of EIDD-2801 or Placebo. Part 3: Subjects will be randomized to receive twice daily dosing either EIDD-2801 or Placebo.	Randomized, Placebo-Controlled, Double-Blind
21	NCT05195060	TURN-COVID Biobank: The Dutch Cohort Study for the Evaluation of the Use of Neutralizing Monoclonal Antibodies and Other Antiviral Agents Against SARS-CoV-2 (TURN-COVID)	Recruiting	Observational	1000	Drug: casirivimab with imdevimab Monoclonal antibody Drug: sotrovimab Monoclonal antibody Drug: molnupiravir Antiviral agent	•Observational Model: Cohort Time Perspective: Prospective Primary Purpose: Therapeutic effect and Cost-effectiveness