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

Duration of Hospitalization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05222113
• Other study ID #: 148/WM12/KEPK/MHSW
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: September 25, 2021

Study information

• Verified date: January 2022
• Source: Universitas Katolik Widya Mandala Surabaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 25, 2021
• Est. primary completion date: September 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 97 Years

Eligibility

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

Related Conditions & MeSH terms

• Duration of Hospitalization

Intervention

Drug:
• Remdesivir
The patients, based on their clinical condition, got remdesivir OR favipiravir at least five days of treatment. The WHO ordinal scale was used to assess patients' clinical progress in the first and second weeks.

Locations

Country	Name	City	State
Indonesia	Gotong Royong Surabaya Hospital	Surabaya	East Java

Sponsors (1)

Lead Sponsor	Collaborator
Bernadette Dian Novita, MD.,PhD

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical manifestation	Oxygen needs, cough, dyspnea	2 weeks since drug (remdesivir OR favipiravir) administration