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Completed

NCT Number: NCT05222113

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

Completed

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Key information

Conditions

Duration of Hospitalization Clinical Manifestation of COVID-19

Age range

18 year–97 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gotong Royong Surabaya Hospital

Surabaya, East Java, 60119, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remdesivir

Drug

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.

Other names: Favipiravir

Primary outcomes

  1. Clinical manifestation

    Time frame: 2 weeks since drug (remdesivir OR favipiravir) administration

    Oxygen needs, cough, dyspnea

Sponsors and collaborators

Lead sponsor

Bernadette Dian Novita, MD.,PhD

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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