OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA

Completed

• Conditions: Duration of Hospitalization; Clinical Manifestation of COVID-19

• Registration Number: NCT05222113
• Lead Sponsor: Bernadette Dian Novita, MD.,PhD

Brief Summary

In order to compare the effectiveness between Remdesivir and Favipiravir, an observational analytic study using a retrospective cohort design. Eighty-eight medical records of COVID-19 patients from January to August 2021

Detailed Description

Coronavirus Disease 2019 (COVID-19) is an infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2). Antiviral therapies are considered to be one of the COVID-19 treatments. Remdesivir and favipiravir are the antivirals recommended by Indonesia's 3rd COVID-19 Management Guidelines. They have a similar mechanism to inhibit virus replication, specifically by inhibiting RNA-dependent RNA polymerase (RdRp) of the virus. Several studies reported that patients who received these antivirals had a lower duration of hospitalization. However, the effectiveness comparison of remdesivir and favipiravir remains unknown.

An observational analytic study using a retrospective cohort design. Eighty-eight medical records of COVID-19 patients from January to August 2021 are collected by consecutive sampling technique, and this research was carried out at Gotong Royong Hospital Surabaya.

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2021-09-25
• Study Completion: 2021-09-25
• Status Verified: 2022-01
• Study First Submitted: 2022-01-23
• Study First Submitted QC: 2022-01-23
• Last Update Submitted: 2022-01-23
• Study First Posted: 2022-02-03
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• Adult patients (eighteen years old or above) with moderate to severe COVID-19 (categorized based on KEPUTUSAN MENTERI KESEHATAN REPUBLIK INDONESIA NOMOR HK. 01. 07/MENKES/413/2020);
• Admitted to Gotong Royong Hospital Surabaya from January 2021 to August 2021;
• Received remdesivir OR favipiravir with minimal five days of treatment
• Not in pregnancy and lactating condition

Exclusion Criteria

• female patient with pregnancy and lactation
• patient whom was passed away or forced home during two-weeks observation period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical manifestation	2 weeks since drug (remdesivir OR favipiravir) administration	Oxygen needs, cough, dyspnea

Trial Locations

Locations (1)

Gotong Royong Surabaya Hospital; 🇮🇩 Surabaya, East Java, Indonesia