Complication of Medical CareFavRemNCT04727775
Antiviral Drugs on the Treatment of SARS-CoV-2
An observational study of Complication of Medical Care and Pneumonia, Viral, run by Astana Medical University at 2 sites in Kazakhstan.
Trial summary
Retrospective Non-Randomized Analytical Cohort Study of Completed SARS-CoV2 COVID19 Cases Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Medical Care, Pneumonia, Viral
- What is being tested?
- Favipiravir and Remdesivir
- How many people
- 150 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 1 Dec 2020to 25 Jul 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients with previous covid 19 pneumonia
Who may be able to join
- main group
- Patients with COVID19 with medium and easy condition disease
- take favipiravir/remdisivir control group
- Patients with COVID19 with medium and easy condition disease
- not take favipiravir/remdisivir
Who cannot join
- patients younger 18
- severe conditionis
Trial locations and contacts
2 sites in 1 country.
Kazakhstan2 sites
Aidos Konkaev
Astana, 010000
Semey Medical University
Semey, 071407
About this study
Official title: A Retrospective Study of the Effect of Antiviral Drugs on the Treatment of SARS-CoV-2 COVID19
Retrospective Non-Randomized Analytical Cohort Study of Completed SARS-CoV2 COVID19 Cases
Read the detailed description
Analyzing the case histories of patients with SARS-CoV2 COVID19 infection and the impact on the outcomes of prescribing antiviral drugs
- Conditions
- Complication of Medical Care, Pneumonia, Viral
- Being tested
- Favipiravir, Remdesivir
- Medical subject headings
- Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Antiviral drugs
RemdesivirDrug
Antiviral drugs
| Study group | Role | What they receive |
|---|---|---|
| Complications | Evaluathion Receives: Drug: Favipiravir; Drug: Remdesivir | |
| Oxygen status | Evaluathion Receives: Drug: Favipiravir; Drug: Remdesivir | |
| Oxugen support | Evaluathion Receives: Drug: Favipiravir; Drug: Remdesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome without comlications
The recovery time will be evaluated with and without antiviral drugs retrospectively in homogeneous groups of patients with SARS-CoV2
Measured: 14 days
Secondary outcomes (4)
Heart rate
Measure
Measured: 14 days
SpO2
Measure
Measured: 14 days
Blood pressure
Measure
Measured: 14 days
Respiratory rate
Measure
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 Jan 2021
- Study start1 Dec 2020
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Medical CareStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astana Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aidos Konkayev, Astana Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727775
- Sponsor's protocol ID
- AMU
- Acronym
- FavRem
- Status last verified
- Aug 2023
- First submitted
- 22 Jan 2021
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Retrospective study
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of the Effect of Antiviral Drugs on the Treatment of SARS-CoV-2 COVID19
- ClinicalTrials.gov ID
- NCT04727775
- Acronym / sponsor ID
- FavRem / AMU
- Conditions
- Complication of Medical Care, Pneumonia, Viral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Astana Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 27 Jan 2021 (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.
Retrospective Non-Randomized Analytical Cohort Study of Completed SARS-CoV2 COVID19 Cases
Detailed description
Analyzing the case histories of patients with SARS-CoV2 COVID19 infection and the impact on the outcomes of prescribing antiviral drugs
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Complications | – | Drug: Favipiravir, Drug: RemdesivirEvaluathion |
| Oxygen status | – | Drug: Favipiravir, Drug: RemdesivirEvaluathion |
| Oxugen support | – | Drug: Favipiravir, Drug: RemdesivirEvaluathion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with previous covid 19 pneumonia
Key inclusion criteria (5 listed)
- main group
- Patients with COVID19 with medium and easy condition disease
- take favipiravir/remdisivir control group
- Patients with COVID19 with medium and easy condition disease
- not take favipiravir/remdisivir
Key exclusion criteria (2 listed)
- patients younger 18
- severe conditionis
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 |
|---|---|---|
| FavipiravirAntiviral drugs | Drug | Complications, Oxugen support, Oxygen status |
| RemdesivirAntiviral drugs | Drug | Complications, Oxugen support, Oxygen status |
Primary outcome
Outcome without comlications
Time frame: 14 days
The recovery time will be evaluated with and without antiviral drugs retrospectively in homogeneous groups of patients with SARS-CoV2
4 secondary outcomes
Heart rate
Time frame: 14 days
SpO2
Time frame: 14 days
Blood pressure
Time frame: 14 days
Respiratory rate
Time frame: 14 days
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 2 Aug 2023.
- Individual participant dataSharing planned: No. Retrospective study
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Medical Care and Pneumonia, Viral, run by Astana Medical University at 2 sites in Kazakhstan.
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 5 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 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan. 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?
Outcome without comlications (time frame: 14 days). 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 2 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.