Effect of Remdesivir in the treatment of Covid-19 patients- An Observational Retrospective study

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.