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

A prospective, randomized, double blind, placebo-controlled clinical study to evaluate the efficacy and safety of ES16001 as an adjunct to standard of care treatment on mild to moderate COVID-19 positive subjects undergoing treatment for COVID-19 in Hospital Quarantine (Dedicated Covid Health Centre).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/027775

Enrollment

Registered

2020-09-11

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: ES16001: Elaeocarpus sylvestris var. ellipticus extract Dosage Regimen: 480 mg per day orally for 10 days Control Intervention1: Standard of care treatment plus placebo: Standard of ca

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
1. Faster Recovery: clinical symptoms and subjectâ??s critical state defined on 7-point ordinal scale. 2. Stress: measured by DASS scale 3. Mental Health: measured through a self-perception Hamilton Anxiety Scale 4. General Well-being/Systemic Health: measured through a self perception WHO 5 wellbeing scale 5. RTPCR 6. Prostaglandin E2, TNF alpha, IL-6 Timepoint: Day 1, 5 and 10	—

Secondary

Measure	Time frame
Assessment of the secondary end points parameters compared within and between both the treatment arms: 1. CBC 2. Urinalysis 3. Blood chemistry 4. Vitals (BP, body temperature, pulse, respiration) 5. Occurrence of any AE or SAE 6. HRQOL (Health- Related Quality of Life) Timepoint: Day 1, 5 and 10	—

Countries

India

Contacts

Public ContactSubham Dutta

Syncorp Health Pvt. Ltd

deankwak@syncorp.in8970888899

Outcome results

None listed

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