MortalityNCT04645433
Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit
An observational study of Mortality and Intensive Care Unit, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Effect of Favipiravir and Lopinavir-Ritonavir on Mortality in a Tertiary Center Intensive Care Unit: Single Center Experience Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mortality, Intensive Care Unit
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 15 May 2020
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients admitted to intensive care units (ICU) between March o 10thand May 10th 2020 due to COVID-19 infection were included to the study
Who may be able to join
- 18 Years and older
Who cannot join
- patients younger than 18 years old
- patients who have received both lopinavir-ritonavir and favipiravir sepuentially
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SisliHamidiye Etfal Education and Training Hospital
Istanbul, 34771
About this study
Official title: Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit: Single Center Experience
Effect of Favipiravir and Lopinavir-Ritonavir on Mortality in a Tertiary Center Intensive Care Unit: Single Center Experience
Read the detailed description
Many agents have been given for treatment of COVID-19 infection. "Covid-19 Diagnosis and Treatment Guideline" by Ministry of Health was advised nationwide use of favipiravir or lopinavir-ritonavir although evidence was scarce for the nationwide use of lopinavir-ritonavir or favipiravir to treat COVID-19 at the time of publication date of detailed guideline Favipiravir is a RNA dependent RNA polymerase inhibitor and approved for treatment of influenza in Japan at 2014 The aim of the study was to compare ICU and hospital mortality in patients with favipiravir or lopinavir-ritonavir treatment and compare other laboratory parameters in patients treated with these two antiviral agents.
- Conditions
- Mortality, Intensive Care Unit
- Keywords
- covid 19, favipiravir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Favipiravir therapy | Favipiravir was advised to all patients with severe pneumonia and progressing pneumonia findings or worsening clinical manifestations except pregnant, breast feeding, postpartum woman. PCR results were not waited to start favipiravir in this group of patients and continued if it would be negative but tomography findings were consistent with COVID-19. Loading dose was 1600 mg twice a day. Maintenance dose was 600 mg per 12 hours for four days. | |
| Lopinavir-ritonavir therapy | Lopinavir-ritonavir therapy was used in selected ICU patients before widespread availability of favipiravir (23 March 2020) and/or if favipiravir was contraindicated. Combination of lopinavir 200 mg-ritonavir 50 mg tablet was the given form. It was given as double tablets twice daily for 10-14 days. Patients were accepted as under favipiravir therapy if they had incomplete course of lopinavir-ritonavir therapy (less than 5 days) and followed by favipiravir for 5 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality for ICU
If the patient dies, we have reached an outcome
Measured: 14 days
hospital stay
If the hospital stay exceeds 14 days, we have reached an outcome
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start15 Mar 2020
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Acar Sevinç, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- sultan acar sevinc, Principal investigator, Sisli Hamidiye Etfal Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645433
- Sponsor's protocol ID
- 2854
- Status last verified
- Nov 2020
- First submitted
- 7 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit: Single Center Experience
- ClinicalTrials.gov ID
- NCT04645433
- Acronym / sponsor ID
- 2854
- Conditions
- Mortality, Intensive Care Unit
- Keywords
- covid 19, favipiravir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 27 Nov 2020 (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.
Effect of Favipiravir and Lopinavir-Ritonavir on Mortality in a Tertiary Center Intensive Care Unit: Single Center Experience
Detailed description
Many agents have been given for treatment of COVID-19 infection. "Covid-19 Diagnosis and Treatment Guideline" by Ministry of Health was advised nationwide use of favipiravir or lopinavir-ritonavir although evidence was scarce for the nationwide use of lopinavir-ritonavir or favipiravir to treat COVID-19 at the time of publication date of detailed guideline Favipiravir is a RNA dependent RNA polymerase inhibitor and approved for treatment of influenza in Japan at 2014 The aim of the study was to compare ICU and hospital mortality in patients with favipiravir or lopinavir-ritonavir treatment and compare other laboratory parameters in patients treated with these two antiviral agents.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Favipiravir therapy | – | –Favipiravir was advised to all patients with severe pneumonia and progressing pneumonia findings or worsening clinical manifestations except pregnant, breast feeding, postpartum woman. PCR results were not waited to start favipiravir in this group of patients and continued if it would be negative but tomography findings were consistent with COVID-19. Loading dose was 1600 mg twice a day. Maintenance dose was 600 mg per 12 hours for four days. |
| Lopinavir-ritonavir therapy | – | –Lopinavir-ritonavir therapy was used in selected ICU patients before widespread availability of favipiravir (23 March 2020) and/or if favipiravir was contraindicated. Combination of lopinavir 200 mg-ritonavir 50 mg tablet was the given form. It was given as double tablets twice daily for 10-14 days. Patients were accepted as under favipiravir therapy if they had incomplete course of lopinavir-ritonavir therapy (less than 5 days) and followed by favipiravir for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to intensive care units (ICU) between March o 10thand May 10th 2020 due to COVID-19 infection were included to the study
Key inclusion criteria (1 listed)
- 18 Years and older
Key exclusion criteria (2 listed)
- patients younger than 18 years old
- patients who have received both lopinavir-ritonavir and favipiravir sepuentially
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality for ICU
Time frame: 14 days
If the patient dies, we have reached an outcome
hospital stay
Time frame: 14 days
If the hospital stay exceeds 14 days, we have reached an outcome
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 27 Nov 2020.
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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.
sultan acar sevinc principal investigator
Sisli Hamidiye Etfal Education and Training Hospital
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 Mortality and Intensive Care Unit, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 27 Nov 2020. 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 Turkey (Türkiye). 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?
Mortality for ICU (time frame: 14 days). The study lists 2 primary outcomes in all. 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 27 Nov 2020.