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.

An Open-Label, Two-Arm, Parallel Design, Prospective, Single-Center, Phase 3 study to assess the safety and efficacy of CoroQuil-Zn in comparison to the standard of care for the treatment of mild to moderate COVID-19

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/12/029735

Enrollment

100

Registered

2020-12-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: CoroQuil-Zn 750mg: 750mg x 2, administered orally three times a day for 14 days Control Intervention1: COVID Standard Care: As per the sites COVID SOP

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written signed and dated informed consent (patient or LAR). 2. Both genders, aged >=18 to 3. Patients with RT-qPCR confirmed COVID-19 patients 4. SpO2>=90% and respiratory rate 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

Exclusion criteria: 1. Pregnant and lactating women 2. Children 75 years 3. SpO2 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.

Design outcomes

Primary

Measure	Time frame
Negative result for qRT-PCR testing for COVIDTimepoint: 14 days	—

Secondary

Measure	Time frame
percentage of patients showing negative qRT-PCR earlier than the End of study visitTimepoint: day 5, day 7	—

Countries

India

Contacts

Public ContactDisha Shetty

Samahitha Research Solutions

sri@samahitha.com9742797117

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026