A Phase III Clinical Trial to understand the efficacy and safety of Molnupiravir 800mg in the treatment of patients diagnosed with mild COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/06/034130
- Lead Sponsor
- BDR Pharmaceuticals Internationals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or non-pregnant female adult � 18 years and � 60 Years of age at time of enrolment.
2.Patients diagnosed with mild COVID-19 (quarantine ward/home isolation).
3.Had initial onset of signs/symptoms attributable to COVID-19 for �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.
uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache without any evidence of breathlessness
4.Patients with confirmed RT PCR positive reports
5.Female participants of childbearing potential must meet the following criteria to be enrolled:
i.Have a negative pregnancy test prior to randomization.
ii.Must agree to undergo a follow-up pregnancy test on study day 28.
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 �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
6.Male participants with female partners must have either Surgical sterilization (vasectomy �1 month before screening) OR
Female partner must be of not be of childbearing potential OR
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
7.Subjects who are ready to provide written informed consent and who are
ready to willingly participate and follow the IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures
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.
2.Hospitalization or need for immediate medical attention in the clinical opinion of the study investigator.
3.Haemoglobin <10 g/dL in men and <9 g/dL in women.
4.Platelet count <125,000/L.
5.Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m2
6.Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevated over 5 times the ULN.
7.Patient is Pregnant or lactating women
8.Recipient of SARS-CoV-2 vaccine.
9.Known allergy/sensitivity or any hypersensitivity to components of test drug, or its formulation.
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.
11.Patients currently taking nucleos(t)ide analogues/ immunosuppressive treatments within 30 days of study enrolment or systemic corticosteroids.
12.Presence of a condition, that in the opinion of the investigator, would place the subject at increased risk from study participation.
13.Patients having chronic bronchitis and/or emphysema, psychiatric, musculoskeletal, or cardiovascular diseases.
14.Patients suffering from concurrent systemic diseases, with cardiopulmonary tuberculosis, pulmonary eosinophilia, bronchiectasis, cancer, congestive heart failure, hepatic dysfunction, and neurological disorders.
15.Patients with severe disease, defined as pneumonia plus one of the following: respiratory rate �30 per minute, breathlessness, SpO2 � 92 on room air.
16.Use of systemic corticosteroid therapy (this may affect peripheral muscle function).
17.Subjects who are known cases of immune-compromised or autoimmune condition such as HIV, Hepatitis.
18.ICU Patient and having severe COVID19 symptoms, known chronic kidney disease stage 4 or 5 or receiving dialysis.
19.Inability to take or tolerate oral medications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method