Duration of HospitalizationNCT05222113
OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA
An observational study of Duration of Hospitalization and Clinical Manifestation of COVID-19, run by Bernadette Dian Novita, MD.,PhD at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 18 to 97 years
- Conditions the study is for
- Duration of Hospitalization, Clinical Manifestation of COVID-19
- What is being tested?
- Remdesivir
- How many people
- 87 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2021to 25 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 97 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- female patient with pregnancy and lactation
- patient whom was passed away or forced home during two-weeks observation period
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Being tested
- Remdesivir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
Also called Favipiravir
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical manifestation
Oxygen needs, cough, dyspnea
Measured: 2 weeks since drug (remdesivir OR favipiravir) administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Aug 2021
- Primary completion25 Sep 2021
- Study completion25 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duration of HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernadette Dian Novita, MD.,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bernadette Dian Novita, MD.,PhD, Universitas Katolik Widya Mandala Surabaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222113
- Sponsor's protocol ID
- 148/WM12/KEPK/MHSW
- Status last verified
- Jan 2022
- First submitted
- 23 Jan 2022
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA
- ClinicalTrials.gov ID
- NCT05222113
- Acronym / sponsor ID
- 148/WM12/KEPK/MHSW
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Bernadette Dian Novita, MD.,PhDUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 Sep 2021 (actual)
- Study completion
- 25 Sep 2021 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 97 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- female patient with pregnancy and lactation
- patient whom was passed away or forced home during two-weeks observation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemdesivirAlso: FavipiravirThe 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. | Drug | – |
Primary outcome
Clinical manifestation
Time frame: 2 weeks since drug (remdesivir OR favipiravir) administration
Oxygen needs, cough, dyspnea
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Yes
Related trials for Duration of Hospitalization
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Not yet recruiting
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Duration of Hospitalization, Neonatal Mortality Rate
RecruitingPhase 4
This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time
Femoral Neck Fractures
Active, not recruitingObservational study
Effect of a Focused Point-of-care Ultrasonography Screening Protocol in Hospitalized Patients
Heart Failure, Congestive, Renal Failure Acute Chronic
Not yet recruiting
Comparison of Day Hospitalization Versus Full-Time Hospitalization in the Treatment of Severe Adolescent Obesity
Severe Adolescent Obesity, Adolescent Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duration of Hospitalization and Clinical Manifestation of COVID-19, run by Bernadette Dian Novita, MD.,PhD at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical manifestation (time frame: 2 weeks since drug (remdesivir OR favipiravir) administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.