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.

Phase 3

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/12/029735
• Lead Sponsor: Remedium Therapeutics Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-03-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 114

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 subjectâ??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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified