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An open label, prospective comparative study to evaluate the proposed therapy in adults with mild symptomatic COVID-19 patients receiving the standard treatment of COVID infection.

An open label, prospective comparative study to evaluate potential of the proposed therapy (Tablet Cefixime 200 mg/Tablet Ivermectin 12 mg/Tablet Montelukast 10mg/Syrup Ascoril LS 5 ml) in adults with mild symptomatic COVID-19 patients receiving the standard treatment (Tablet Cefixime 200 mg/Vitamin C, MVBC/Antacids) of COVID infection. - Add on therapy/COVID-19/2020

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027944
Enrollment
30
Registered
2020-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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: Tab.Cefixime 200 mg Tab.Ivermectin 12 mg Tab.Montelukast 10 mg Syp.Ascoril LS 5 ml: Tab.Cefixime 200 mg BD for 5 days Tab.Ivermectin 12 mg OD for day 1 Tab.Montelukast 10 mg OD for 5 da

Sponsors

Public Health Department
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of both Gender aged more than 18 years old. 2.Willing and able to provide written informed consent. 3.Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV2 / COVID) infection confirmed by RT Polymerase chain reaction (RT-PCR) test 4.Currently hospitalized and requiring medical care for COVID-19 5.Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening

Exclusion criteria

Exclusion criteria: 1.Subjects having less than 18 years of age 2.Drug atopy subjects 3.Private positive patients/ Truenaat positive/ Antigen positive 4.Critical comorbities

Design outcomes

Primary

MeasureTime frame
Compared to standard of treatment receiving in COVID -19 infection, proposed regimen if consumed as an add on therapy prescribed by physician as per the clinical conditions and disease outcome will be efficacious in reducing medically attended lung infection caused by RT-PCR-confirmed COVID-19 virus in COVID Positive adults more than age 18 yrs .Timepoint: 14 Days

Secondary

MeasureTime frame
There will be a reduction in the incidence of hospitalizations attributable to COVID-19 in patients treated with proposed regimen There will be minimal chances of respiratory failure in patients due to COVID-19 in patients treated with proposed regimen Timepoint: 14 days

Countries

India

Contacts

Public ContactDr Dhananjay Lad

CROM Clinical Research & Medical Tourism Pvt. Ltd.

laddhl@gmail.com9158592177

Outcome results

None listed

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