Using N-acetylcysteine as therapeutic drug for COVID-19 patients.

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2020/06/026194

Lead Sponsor: Index Medical College and research centre Indore

Brief Summary: | |

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|COVID-19 is a universal emergency, and is characterized by high morbidity and mortality. In this project we aim to examine the effect of N-acetycysteine on alleviating signs and symptoms of SARS CoV-2 infection. This study will be a randomized, double blind, placebo-controlled clinical trial conducted in the corona isolation wards of Index hospital, Indore which is already designated as â€˜Red Zoneâ€™ hospital for treatment of the COVID patients.

**Subjects:**

100 patients will be selected from the admitted patients undergoing COVID-19 treatment in corona ward after signing the informed consent. Stratified patients will be randomly assigned in either NAC group (n=50) or control group (placebo) (n=50). The NAC group will receive N-acetyl cysteine along with the conventional treatment for SARS CoV-2 infection whereas placebo group will be given sugar coated tablets added up with regular conventional treatment.

The symptomatic treatment containing of an expectorant, and will be given to both the groups as and when required. Diary record of all the medications given will be maintained. Patients in the NAC group will receive 600mg/day oral NAC doses for 10 days. Patients will be monitored for the incidence of NAC related side effects and drug interaction. Increase and decrease of NAC doses will be done during the pilot experiment. RT PCR of nasopharyngeal swabs will be performed. Data will be recorded and analyzed for primary and secondary outcomes and interpretations will be made in concern with effectiveness of NAC in COVID treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: All

Target Recruitment: 200

Inclusion Criteria

patients of both genders who aged between 10 years to 55 years with confirmation of COVID-19 infection through RT-PCR test.
Mild to moderate severity of disease who are willing to participate in study by giving written informed consent.

Exclusion Criteria

seriously ill patients requiring ventilators support.
Children below 10 years, adults > 55 years of age.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.Rate of cure from the disease as measured by negative results of RT-PCR test on nasopharyngeal swabs	5-7days from start of dose administration
1.Effect of NAC in the study group on alleviating patientâ€™s signs and Symptoms of COVID-19 in forms of severity and duration.	5-7days from start of dose administration

Secondary Outcome Measures

Name	Time	Method
1.Incidence of the adverse effects in both the group.	2.Association of age and gender with the clinical outcome in COVID-19 patients.

Trial Locations

Locations (1): NAME OF SITE: Index Medical College Hospital & Research Centre
🇮🇳
Indore, MADHYA PRADESH, India
NAME OF SITE: Index Medical College Hospital & Research Centre
🇮🇳Indore, MADHYA PRADESH, India
Dr Neha Jaiswal
Principal investigator
8949988510
jaisneha411@gmil.com