FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/10/028657 [Registered on: 27/10/2020] Trial Registered Prospectively
Last Modified On: 18/04/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Remdesivir effect in the treatment of corona 
Scientific Title of Study   Effect of Remdesivir in the treatment of Covid-19 patients- An Observational Retrospective study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mitul Upadhyay 
Designation  PG student 
Affiliation  Government medical college Bhavnagar 
Address  Department of pharmacology, Government medical college bhavnagar, behind ST bus stand, Bhavnagar 364001.

Bhavnagar
GUJARAT
364001
India 
Phone  9409386446  
Fax    
Email  drmitulupadhyay@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mitul Upadhyay 
Designation  PG student 
Affiliation  Government medical college Bhavnagar 
Address  Department of pharmacology, Government medical college bhavnagar, behind ST bus stand, Bhavnagar 364001.

Bhavnagar
GUJARAT
364001
India 
Phone  9409386446  
Fax    
Email  drmitulupadhyay@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mitul Upadhyay 
Designation  Resident doctor 
Affiliation  Government medical college Bhavnagar 
Address  Department of pharmacology, Government medical college bhavnagar, behind ST bus stand, Bhavnagar 364001.

Bhavnagar
GUJARAT
364001
India 
Phone  9409386446  
Fax    
Email  drmitulupadhyay@gmail.com  
 
Source of Monetary or Material Support  
Dr Mitul Upadhyay, department of pharmacology, Government medical college bhavnagar, Bhavnagar 364001 
 
Primary Sponsor  
Name  Department of pharmacology 
Address  Department of pharmacology, Government medical college Bhavnagar, Bhavnagar 364001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Department of medicine  Department of medicine, Sir T hospital, bhavnagar 364001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mitul Upadhyay  Sir T hospital bhavnagar  department of medicine,corona case record room
Bhavnagar
GUJARAT 		 9409386446

drmitulupadhyay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethical committee, Government medical college, bhavnagar  Approved 
Ethical committee, Government medical college, bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Covid rapid test positive or Rt-PCR test positive

SpO2 level less than 94% or Xray suggestive of pneumonia.
 
 
ExclusionCriteria 
Details  Patients file with incomplete details 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in SpO2 level and severity score
Reduction in hospital stay and ICU stay
Reduction in mortality
Safety profile of remdesivir  		 Reduction in SpO2 level and severity score at day 1,3,5,7,10,14,21,28
Reduction in hospital stay and ICU stay at day 28
Reduction in mortality at final outcome(death or discharge of patient)
Safety profile of remdesivir (till discharge or death of patients) 
 
Secondary Outcome  
Outcome  TimePoints 
Safety profile of remdesivir  Till final outcome 
 
Target Sample Size   Total Sample Size="275"
Sample Size from India="275" 
Final Enrollment numbers achieved (Total)= "1193"
Final Enrollment numbers achieved (India)="1193" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/10/2020 
Date of Study Completion (India) 05/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Title: Effect of Remdesivir in treatment of Covid-19 patients- An Observational Retrospective study”

Introduction: No proven effective therapies for corona virus currently exist. The rapidly expanding knowledge regarding SARS-CoV-2 virology provides a significant number of potential drug targets. The most promising therapy is remdesivir. Remdesivir has potent in vitro activity against SARS-CoV-2. RdRp is the RNA polymerase responsible for viral RNA synthesis that may be blocked by antiviral drugs or drug candidates, such as remdesivir. Role of Remdesivir in shortening of recovering time and improving clinical outcome in covid 19 case is not well known.

Research Question: Is there any effect of Remdesivir in the treatment of Covid 19?

Aim/Goal: To study the effect of remdesivir in the treatment of Covid-19 positive patients.

Objectives:1) To assess the difference in the change in SpO2 level and Severity score between both group. 2)To assess the difference in the average hospital stay and ICU stay. 3)To assess the final outcome of the patients in both group. 4) To assess the percentage of patients with adverse effects of remdesivir.

Study design/type: A retrospective, observational comparative study

Study population: Case files of covid 19 positive patients

 Sample Size: All Covid 19 positive patients between 1-4-2020 to 30-9-2020 and admitted to SirT hospital

Study duration: 12 months

Study site: Record room of covid 19 positive patients, SirT hospital, Bhavnagar

Study procedures: After receiving approval from ethics committee study will be carried out, Data will be taken from the case files of patients from the case record room for covid patients and noted in the CRF.

Inclusion criteria:

     Covid rapid test positive or Rt-PCR test positive

       SpO2 level less than 94% or Xray suggestive of pneumonia.

Exclusion criteria: Patients file with incomplete details

Group A: Patients who have received standard treatment.

Group B: Patients Who have received standard treatment plus Remdesivir

Data recorded from case files:

Drug prophylaxis history

Co-morbid condition

Concomitant medication treatment

SpO2 level, respiratory rate and severity score(Lowest SpO2 level, Highest RR and Highest severity score for that day will be taken)(At day 1,3,5,7,10,14,21,28)

Adverse effects

X-ray and HRCT findings

Laboratory data (At day 1,3,5,7,10,14,21,28)

Outcome will be measured as- Discharge / Death

·        Outcome variables: Improvement in SpO2 level and severity score.

·                                               Safety profile of Remdesivir

·                                               Minimize the hospital stay and ICU duration    

                                            Reduce the mortality in the patients

       Appropriate statistical test will be applied.

Severity score:

The six-point scale for severity is as follows:

 death=6
hospital admission for invasive ventilation=5
hospital admission for non-invasive ventilation or high-flow oxygen therapy=4
hospital admission for oxygen therapy (but not requiring high-flow  ventilation)=3
hospital admission but not requiring oxygen therapy=2
discharged =1
Publication: of this study will be done without any sensitive information about the patient or patient names.
Because effect of remdesivir in covid 19 is not extensively studied in India this study will be carried out to know the effect on course and mortality in patients of covid 19.
 
Close