COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56281

Mukesh Kumar

mukesh@rahelife.com

2021-06-10

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1.Male or non-pregnant female adult â?¥ 18 years and â?¤ 60 Years of age at time of enrolment. <br/ >2.Patients diagnosed with mild COVID-19 (quarantine ward/home isolation). <br/ >3.Had initial onset of signs/symptoms attributable to COVID-19 for â?¤5 days prior to the day of randomization and at least 1 of the following sign/symptoms attributable to COVID-19 on the day of randomization. <br/ >uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache without any evidence of breathlessness <br/ >4.Patients with confirmed RT PCR positive reports <br/ >5.Female participants of childbearing potential must meet the following criteria to be enrolled: <br/ >i.Have a negative pregnancy test prior to randomization. <br/ >ii.Must agree to undergo a follow-up pregnancy test on study day 28. <br/ >Note that female not of childbearing potential is defined as either:Surgically sterile: Females who are permanently sterile via hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy by reported medical history and/or medical records. Surgical sterilization to have occurred a minimum of 6 weeks, or at â?¢ For female subjects: evidence of post-menopause, or for pre- menopause subjects, negative pre-treatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment <br/ >6.Male participants with female partners must have either Surgical sterilization (vasectomy â?¥1 month before screening) OR <br/ >Female partner must be of not be of childbearing potential OR <br/ >Agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment <br/ >7.Subjects who are ready to provide written informed consent and who are <br/ >ready to willingly participate and follow the IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures <br/ > <br/ > <br/ >

1.Subjects who are not able to or not willing to sign an IRB/IEC approved consent form or refusal to participate by legally authorized representative, if present. <br/ >2.Hospitalization or need for immediate medical attention in the clinical opinion of the study investigator. <br/ >3.Haemoglobin <10 g/dL in men and <9 g/dL in women. <br/ > <br/ >4.Platelet count <125,000/L. <br/ > <br/ >5.Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m2 <br/ > <br/ >6.Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevated over 5 times the ULN. <br/ >7.Patient is Pregnant or lactating women <br/ > <br/ >8.Recipient of SARS-CoV-2 vaccine. <br/ > <br/ >9.Known allergy/sensitivity or any hypersensitivity to components of test drug, or its formulation. <br/ > <br/ >10.Use of therapeutic interventions with possible anti-SARS-CoV-2 activity within 30 days prior to study entry, e.g., remdesivir, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, convalescent plasma, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis. <br/ >11.Patients currently taking nucleos(t)ide analogues/ immunosuppressive treatments within 30 days of study enrolment or systemic corticosteroids. <br/ >12.Presence of a condition, that in the opinion of the investigator, would place the subject at increased risk from study participation. <br/ >13.Patients having chronic bronchitis and/or emphysema, psychiatric, musculoskeletal, or cardiovascular diseases. <br/ >14.Patients suffering from concurrent systemic diseases, with cardiopulmonary tuberculosis, pulmonary eosinophilia, bronchiectasis, cancer, congestive heart failure, hepatic dysfunction, and neurological disorders. <br/ >15.Patients with severe disease, defined as pneumonia plus one of the following: respiratory rate â?¥30 per minute, breathlessness, SpO2 â?¤ 92 on room air. <br/ >16.Use of systemic corticosteroid therapy (this may affect peripheral muscle function). <br/ >17.Subjects who are known cases of immune-compromised or autoimmune condition such as HIV, Hepatitis. <br/ >18.ICU Patient and having severe COVID19 symptoms, known chronic kidney disease stage 4 or 5 or receiving dialysis. <br/ >19.Inability to take or tolerate oral medications.

2

BDR Pharmaceuticals Internationals Pvt Ltd

18

60

India

Mild disease at enrollment

1: Mild disease at enrollment

1218

To evaluate the efficacy of Molnupiravir compared to standard of care in confirmed RT-PCR positive patients with mild COVID-19Timepoint: Rate of hospitalization from randomization up to Day 14

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

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