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

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

Study Overview

• Status: Completed
• Conditions: Duration of Hospitalization; Clinical Manifestation of COVID-19
• Intervention / Treatment: Drug: Remdesivir

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 Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• Indonesia
  • East Java
    • Surabaya, East Java, Indonesia, 60119
      • Gotong Royong Surabaya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 97 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients' medical records from Gotong Royong Surabaya Hospital were obtained from January 2021 to March 2021 and June 2021 to August 2021, since remdesivir was rarely used from April 2021 to May 2021.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical manifestation	Oxygen needs, cough, dyspnea	2 weeks since drug (remdesivir OR favipiravir) administration

Collaborators and Investigators

• Sponsor: Bernadette Dian Novita, MD.,PhD

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2021
• Primary Completion (ACTUAL): September 25, 2021
• Study Completion (ACTUAL): September 25, 2021

Study Registration Dates

• First Submitted: January 23, 2022
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (ACTUAL): February 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Favipiravir; Remdesivir
• Other Study ID Numbers: 148/WM12/KEPK/MHSW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No