Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: COVIMABS & SOC: 1) Details :- A total of 32 subjects in phase 1 study in the four cohorts (6 ZRC COVIMABS plus SOC + 2 SOC in each cohort)
2)Dose :-300mg,600mg,1200mg,2400mg
3)Route:-I
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male or female subjectââ?¬•s ââ?°Â¥ 18 years. 2.Positive for COVID-19 by an approved test (RT PCR). 3.Subjects with COVID-19 with mild disease and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Mild disease defined as upper respiratory tract symptoms &/or fever WITHOUT shortness of breath or hypoxia. (Reference: Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 24 May 2021). High risk is defined as: Subjects who meet at least one of the following criteria: ââ?¬Â¢Age > 60years OR ââ?¬Â¢Cardiovascular disease, hypertension, OR CAD OR ââ?¬Â¢DM (Diabetes mellitus) OR other immunocompromised states OR ââ?¬Â¢Chronic lung/kidney/liver disease OR ââ?¬Â¢Cerebrovascular disease OR ââ?¬Â¢Obesity (BMI ââ?°Â¥ 30 kg/m2) 4.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study. 5.Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol. 6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of study dose.
Exclusion criteria
Exclusion criteria: 1.Evidence of moderate or severe COVID-19 disease as per the Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 17 May 2021. (Moderate disease: Any one of (1) Respiratory rate � 24/min, breathlessness; (2) SpO2 90% to � 93% on room air) (Severe disease: Any one of (1) Respiratory rate >30/min, breathlessness; (2) SpO2 2.Onset of COVID-19 symptoms before 5 days from planned study drug administration. 3.Current hospitalization due to COVID at the time of screening. 4.Has a documented infection other than COVID-19. 5.Has received a COVID-19 vaccine (For Phase 2: However, vaccinated subjects who are infected can be enrolled based on a case by case basis). 6.Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. 7.Has a history of hypersensitivity reactions to therapeutic proteins. 8.Pregnant or lactating and breast feeding or planning on either during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of ZRC COVIMABS plus SOC compared to SOC alone up to 14 daysTimepoint: baseline to 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the immunogenicity of ZRC COVIMABS.Timepoint: Baseline to Day 14;To characterize the Pharmacokinetic profiles of ZRC COVIMABS in serum.Timepoint: Baseline to Day 14;To evaluate the clinical efficacy of ZRC COVIMABS plus SOC compared to SOC alone.Timepoint: baseline to 14 days & 30 days;To evaluate the safety and tolerability of ZRC COVIMABS plus SOC compared to SOC alone up to 90 days.Timepoint: baseline to day 90;To evaluate the virologic efficacy of ZRC COVIMABS plus SOC compared to SOC alone in reducing viral shedding of SARS-CoV-2.Timepoint: Baseline to days 3, 5, 8, 11, and 14 | — |
Countries
India
Contacts
Public ContactDr Taufik Momin
Cadila Healthcare Limited
Outcome results
None listed