NCT05222113

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

January 23, 2022

Last Update Submit

January 23, 2022

Conditions

Duration of HospitalizationClinical Manifestation of COVID-19

Outcome Measures

Primary Outcomes (1)

  • Clinical manifestation

    Oxygen needs, cough, dyspnea

    2 weeks since drug (remdesivir OR favipiravir) administration

Interventions

RemdesivirDRUG

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.

Also known as: Favipiravir

Eligibility Criteria

Age18 Years - 97 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • female patient with pregnancy and lactation
  • patient whom was passed away or forced home during two-weeks observation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gotong Royong Surabaya Hospital

Surabaya, East Java, 60119, Indonesia

Location

MeSH Terms

Interventions

remdesivirfavipiravir

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD.,PhD

Study Record Dates

First Submitted

January 23, 2022

First Posted

February 3, 2022

Study Start

August 1, 2021

Primary Completion

September 25, 2021

Study Completion

September 25, 2021

Last Updated

February 3, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

ID(1)