FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/06/026194 [Registered on: 28/06/2020] Trial Registered Prospectively
Last Modified On: 27/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Using N-acetylcysteine as therapeutic drug for COVID-19 patients. 
Scientific Title of Study   A randomized, double blind, placebo controlled, comparative study to investigate the efficacy of N-acetylcysteine in COVID-19 patients with standard therapy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NCT04374461  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Jaiswal 
Designation  principal Investigator 
Affiliation  Index Medical College and research centre, Indore 
Address  Dept. of Pharmacology, Index Medical College, Hospital and Research Centre, Nemawar Road Indore (MP)

Indore
MADHYA PRADESH
452016
India 
Phone  8949988510  
Fax    
Email  jaisneha411@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prem Nyati 
Designation  Professor and Head 
Affiliation  Index Medical College and research centre, Indore 
Address  Dept. of Pharmacology, Index Medical College, Hospital and Research Centre, Nemawar Road Indore (MP)

Indore
MADHYA PRADESH
452016
India 
Phone  9826230936  
Fax    
Email  drpremnyati@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Neha Jaiswal 
Designation  principal Investigator 
Affiliation  Index Medical College and research centre, Indore 
Address  Dept. of Pharmacology, Index Medical College, Hospital and Research Centre, Nemawar Road Indore (MP)

Indore
MADHYA PRADESH
452016
India 
Phone  8949988510  
Fax    
Email  jaisneha411@gmail.com  
 
Source of Monetary or Material Support  
4. Index Medical College Hospital & Research Centre, Index City,Gram Morodhat Nh-59 A, Nemawar Road Near Khudel Indore,MP 
 
Primary Sponsor  
Name  Index Medical College and research centre Indore 
Address  Index Medical College and research centre, Indore 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neha Jaiswal  NAME OF SITE: Index Medical College Hospital & Research Centre  SITE ADDRESS: The proposed study will be conducted in corona isolation wards of Index hospital Indore. The hospital is designated as ‘Red Zone’ hospital for treatment of corona patients.
Indore
MADHYA PRADESH 
8949988510

jaisneha411@gmil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Index medical college Indore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  glucose capsule  similar capsule containing glucose 600 mg will be given oral daily twice a day for 10 days.  
Intervention  N-acetylcysteine  N-acetyl cysteine (NAC)oral administration in dose of 600 mg daily twice a day for 10 days. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  seriously ill patients requiring ventilators support.
Children below 10 years, adults > 55 years of age.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1. Effect of NAC in the study group on alleviating patient’s signs and Symptoms of COVID-19 in forms of severity and duration.
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 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of the adverse effects in both the group.
2. Association of age and gender with the clinical outcome in COVID-19 patients.
3. Progression of the patient towards severity of disease.
 
1-10 days from start of dose administration 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/06/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Brief Summary  

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 ‘Red Zone’ 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.

 

 
Close