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

• Sponsor: Bernadette Dian Novita, MD.,PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT05222113
• Collaborator: (none)
• Enrollment: 87
• Location: 1
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 48.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Duration of Hospitalization; Clinical Manifestation of COVID-19	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 Design

• Study Type: Observational
• Actual Enrollment: 87 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA
• Actual Study Start Date: Aug 1, 2021
• Actual Primary Completion Date: Sep 25, 2021
• Actual Study Completion Date: Sep 25, 2021

Outcome Measures

Primary Outcome Measures

1. Clinical manifestation [2 weeks since drug (remdesivir OR favipiravir) administration]

   Oxygen needs, cough, dyspnea

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 97 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gotong Royong Surabaya Hospital	Surabaya	East Java	Indonesia	60119

Sponsors and Collaborators

• Bernadette Dian Novita, MD.,PhD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bernadette Dian Novita, MD.,PhD, MD.,PhD, Universitas Katolik Widya Mandala Surabaya
• ClinicalTrials.gov Identifier: NCT05222113
• Other Study ID Numbers: 148/WM12/KEPK/MHSW
• First Posted: Feb 3, 2022
• Last Update Posted: Feb 3, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Favipiravir; Remdesivir

Study Results

No Results Posted as of Feb 3, 2022