Remdesivir effect in the treatment of corona
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/10/028657
- Lead Sponsor
- Department of pharmacology
- Brief Summary
**Title**: Effect of Remdesivir in treatment of Covid-19 patients- An Observational Retrospective studyâ€
**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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 275
Covid rapid test positive or Rt-PCR test positive SpO2 level less than 94% or Xray suggestive of pneumonia.
Patients file with incomplete details.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in hospital stay and ICU stay 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) Reduction in mortality 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) 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) Reduction in SpO2 level and severity score 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 Measures
Name Time Method Safety profile of remdesivir Till final outcome
Trial Locations
- Locations (1)
Sir T hospital bhavnagar
🇮🇳Bhavnagar, GUJARAT, India
Sir T hospital bhavnagar🇮🇳Bhavnagar, GUJARAT, IndiaDr Mitul UpadhyayPrincipal investigator9409386446drmitulupadhyay@gmail.com