COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44639

Mr Sohal Pendse

v.deshmukh@prorelixresearch.com

2020-08-13

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. 50 years or older <br/ >2. Both male and female subjects will be included <br/ >3. Positive oropharyngeal/nasal swab RT-PCR for Sars-Co-V2. Diagnosed not more than 2 days ago (diagnosis �2days). <br/ >4. Either asymptomatic or have mild symptoms. Onset of symptoms within no more than 4 days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) ( <10mg/L). There are no signs of dehydration, sepsis or shortness of breath. <br/ >5. Chronic stable medical conditions: diabetes mellitus, or hypertension, or chronic heart disease. Under treatment and controlled by medication <br/ >6. Signed informed consent/or consent given through text message, WhatsApp or e-mail. <br/ >7. Ability to understand the requirements of the Research Protocol and follow the research procedures. <br/ >8. Subject should be willing to be managed in isolation wards <br/ >9. Negative pregnancy test (for female participants) <br/ >10. Adequate contraception for study duration <br/ >

1. Less than 50 years <br/ >2. With severe COVID-19 symptoms requiring immediate hospitalization <br/ >3. Investigator considers the subject unsuitable for ViraCide <br/ >4. History of symptoms of more than 4 days <br/ >5. COVID-19 diagnosed >2 days ago using oropharyngeal/nasal swab RT-PCR for Sars-Co-V2 <br/ >6. History of cardiopulmonary resuscitation <br/ >7. Subjects having history of organ failure or conditions requiring ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation or any other condition that in the PIâ??s opinion makes the subject unfit to participate <br/ >8. Respiratory failure, ARDS or need of mechanical ventilation <br/ >9. History of acute exacerbation of comorbidity like heart failure, diabetic kedoacidosis, myocardial infection, major cardiac rhythm disorder or any other condition that in the PIâ??s opinion makes the subject unfit to participate <br/ >10. History of or current hepatic failure or severely compromised liver function, or renal failure or having chronic kidney disease or acute renal failure <br/ >11. History of or currently receiving treatment for an endocrine disorder like hypothyroidism, hyperthyroidism that is likely to affect the basal heart rate. <br/ >12. History of or currently under treatment for asthma [exception: patients with history of asthma, not on medications/inhalers/nebulizers for at least 6 months before study start), COPD, bronchiectasis, asbestosis and other such chronic lung conditions that can compromise SpO2 and RR. <br/ >13. HIV, HBsAg, HCV positive <br/ >14. Any condition causing immunodeficiency <br/ >15. Systemic connective tissue disease or any autoimmune disease that is likely to affect HS-CRP levels <br/ >16. History of epilepsy/epileptic fit/convulsions in last 6 months or currently on treatment for it <br/ >17. History of or currently having malignancy and being treated for it. (exception: histologically confirmed and cured carcinoma in situ) <br/ >18. Hypersensitivity reaction to Study drug/placebo <br/ >19. Any psychiatric issue for which the subject is currently undergoing treatment <br/ >20. Any history of drug/alcohol dependence within 30 days of screening or current drug/alcohol dependence <br/ >21. Inability to understand the requirements of the Research Protocol and follow the research procedures. <br/ >22. Pregnant or lactating, <br/ >23. Not willing to use adequate contraception during study duration <br/ >24. Participation in any other clinical study less than 3 months before the start of the study. <br/ >

2

Natural Supplemets LLC

50

70

India

Mild disease at enrollment

1: Mild disease at enrollment

120

1. To evaluate the efficacy of â??ViraCideâ?? in the management of mild COVID-19 diseaseTimepoint: Baseline; day 7 and day 15

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

Not reported

[{"arm_notes": "", "treatment_id": 1362, "treatment_name": "Viracide", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]