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

NCT ID: NCT05222113

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2021-09-25

Brief Summary

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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

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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.

Conditions

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Duration of Hospitalization Clinical Manifestation of COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Favipiravir

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

97 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bernadette Dian Novita, MD.,PhD

OTHER

Sponsor Role lead

Responsible Party

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Bernadette Dian Novita, MD.,PhD

MD.,PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Gotong Royong Surabaya Hospital

Surabaya, East Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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148/WM12/KEPK/MHSW

Identifier Type: -

Identifier Source: org_study_id

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