| CTRI Number |
CTRI/2020/06/026194 [Registered on: 28/06/2020] Trial Registered Prospectively |
| Last Modified On: |
08/02/2021 |
| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 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)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. | |