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A study to evaluate the effect of Oral Niclosamide in mild and very mild COVID-19 cases

EFFICACY OF ORAL NICLOSAMIDE IN TREATMENT OF MILD AND VERY MILD COVID-19 CASES: AN OPEN-LABEL RANDOMIZED CONTROLLED TRIAL - EONIC-COVID

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024949
Enrollment
48
Registered
2020-04-30
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 Health Condition 2: B338- Other specified viral diseases

Interventions

Intervention1: Niclosamide: 500 mg bid for 7-14 days Control Intervention1: Standard of care: As per MoHFW, GoI guidelines

Sponsors

Lady Hardinge Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Adult patients (>=18years) suffering from mild or very mild Covid-19 (8). A positive throat swab for nCoV-2019 (by real time PCR) obtained from a patient suspected to be Covid-19 or from a contact (or HCW) of Covid-19 patient will be considered to be a Covid-19 case, irrespective of the presence of symptoms. Mild disease will be defined as respiratory rate between 12-18/minute and SpO2 >= 95% in room air and no clinico-radiological (normal chest X-ray) signs of pneumonia.

Exclusion criteria

Exclusion criteria: • Patients with renal or hepatic dysfunction (Serum creatinine > 1.5 mg/dL and serum transaminase levels >120 U/L) • Patients with clinical heart failure/known CAD • Known cases of neoplasms or immunodeficiency syndromes • Patients who are on chemotherapy, immunosuppressive agents, steroids or antiviral agents, or have received in the preceding 4 weeks • Pregnant and lactating patients • Uncooperative patients (in the opinion of the investigator, if it is difficult to ensure patient cooperation during the study)

Design outcomes

Primary

MeasureTime frame
Proportion of patients having virologic cure on Day 6 in both the groupsTimepoint: Day 6 of treatment initiation

Secondary

MeasureTime frame
o Proportion of patients having resolution of symptoms on Day 7 and Day 14 in both the groups o The individual proportion of aforementioned rescue criteria in both the groups. o Side-effects (adverse events) noted in both the groups Timepoint: 7 and 14 days

Countries

India

Contacts

Public ContactAnupam Prakash

LADY HARDINGE MEDICAL COLLEGE

prakashanupam@hotmail.com8588885305

Outcome results

None listed

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