COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58714

Dr Taufik Momin

Taufik.Momin@zyduscadila.com

2021-08-31

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Adult male or female subjectâ??s â?¥ 18 years. <br/ >2.Positive for COVID-19 by an approved test (RT PCR). <br/ >3.Subjects with COVID-19 with mild disease and who are at high risk for progressing to severe COVID-19 and/or hospitalization. <br/ >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). <br/ >High risk is defined as: Subjects who meet at least one of the following criteria: <br/ >â?¢Age > 60years OR <br/ >â?¢Cardiovascular disease, hypertension, OR CAD OR <br/ >â?¢DM (Diabetes mellitus) OR other immunocompromised states OR <br/ >â?¢Chronic lung/kidney/liver disease OR <br/ >â?¢Cerebrovascular disease OR <br/ >â?¢Obesity (BMI â?¥ 30 kg/m2) <br/ >4.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study. <br/ >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. <br/ >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. <br/ >

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. <br/ >(Moderate disease: Any one of (1) Respiratory rate â?¥ 24/min, breathlessness, (2) SpO2 90% to â?¤ 93% on room air) <br/ >(Severe disease: Any one of (1) Respiratory rate >30/min, breathlessness, (2) SpO2 < 90% on room air) <br/ >2.Onset of COVID-19 symptoms before 5 days from planned study drug administration. <br/ >3.Current hospitalization due to COVID at the time of screening. <br/ >4.Has a documented infection other than COVID-19. <br/ >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). <br/ >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. <br/ >7.Has a history of hypersensitivity reactions to therapeutic proteins. <br/ >8.Pregnant or lactating and breast feeding or planning on either during the study. <br/ >

2

Cadila Healthcare Ltd

18

85

India

Mild disease at enrollment

1: Mild disease at enrollment

332

To evaluate the safety and tolerability of ZRC COVIMABS plus SOC compared to SOC alone up to 14 daysTimepoint: baseline to 14 days

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

Phase 1/Phase 2

[{"arm_notes": "300mg,600mg,1200mg,2400mg", "treatment_id": 1895, "treatment_name": "Zrc-3308", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]