A Study to Assess the Safety and Efficacy of CoroQuil-Zn 750 in Comparison to the Standard of Care for the Treatment of Mild to Moderate COVID-19.
CTRI; 11-12-2020; TrialID: CTRI/2020/12/029735
Clinical Trial Register
| ICTRP | ID: ictrp-CTRI202012029735
ABSTRACT
Condition
Health Condition 1 B972- Coronavirus as the cause of diseases classified elsewhereIntervention
Intervention1 CoroQuil-Zn 750mg 750mg x 2, administered orally three times a day for 14 daysControl Intervention1 COVID Standard Care As per the sites COVID SOP
Primary outcome:
Negative result for qRT-PCR testing for COVIDTimepoint 14 daysCriteria
Inclusion criteria 1. Written signed and dated informed consent (patient or LAR).2. Both genders, aged >=18 to <=75 years,
3. Patients with RT-qPCR confirmed COVID-19 patients
4. SpO2>=90% and respiratory rate <=30/minute
5. Healthy adult patients with ASA I to II
6. A score of between 3 to 5 on the Modified WHO Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1)
7. Patients who agree to abide by the study requirements
Exclusion criteria 1. Pregnant and lactating women
2. Children <18 yrs. of age; elderly >75 years
3. SpO2 <90% for adults and respiratory rate >30/minute
4. Patients having persistent nausea/vomiting
5. Need for direct admission to the intensive care unit for mechanical ventilation
6. Underlying chronic obstructive pulmonary disease stage III-IV
7. Patients simultaneously participating in another clinical study.
8. History of stroke with significant neurologic deficit.
9. Patients with any concurrent pre-existing severe/uncontrolled, clinically significant systemic disease [e.g. heart failure (NYHA 2 or above)], cancer, liver disease, kidney disease or anaemia etc.) that, in the opinion of investigator precludes the subject´s participation in the study or interferes with the interpretation of the study results.
10. Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
11. Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
12. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
Collection:
Clinical trial registers
Database:
ICTRP
Year:
2020
Document Type:
Clinical Trial Register
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