Efficacy and safety clinical study of ES16001 as an adjunct in COVID positive patients.

Phase 2

Completed

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

• Registration Number: CTRI/2020/09/027775
• Lead Sponsor: GENECELL CO LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Male or self-reported non-pregnant female between 20 to 65 years (both inclusive) of age at the time of enrolment.

2. Subject or LAR providing written informed consent and agrees to follow study procedure.

3. Woman with child bearing potential confirming use of primary contraception.

4. Mild to moderate freshly confirmed COVID-19 positive report in less than 24 hours not requiring emergency or ICU care at the time of enrolment.

Exclusion Criteria

1. Severe COVID-19 patients requiring ventilation or oxygen support when diagnosed.

2. Females who are planning to conceive during the study duration or are pregnant already (self-reported) or are breastfeeding.

3. Subjects having serious or unstable respiratory disorders (selfreported).

4. Subject already on immune therapy (self-reported). 5. History of Immunodeficiency or organ transplant (self-reported).

6. Presence of Autoimmune disease (self-reported).

7. Current acute infection or exacerbation of a chronic illness (selfreported).

8. Cancer within last 5 years (self-reported).

9. Known infection with HIV, Hepatitis B & Hepatitis C (self-reported).

10. Drug abuse/alcohol abuse (self-reported).

11. Patients with severe cardiac pathologies or any chronic illness or comorbid illness (self-reported). 12. Patients on treatment for Diabetes Mellitus (self-reported).

13. Patients with the history of neurological or psychiatric illness (selfreported).

14. Receiving blood or immunoglobulins within 3 months (selfreported).

Study & Design

• Study Type: Interventional
• Study Design: Not specified