COVID19FACCTNCT04392973
FAvipiravir and HydroxyChloroquine Combination Therapy
A study testing Favipiravir and Hydroxychloroquine in people with COVID19, run by King Abdullah International Medical Research Center at 8 sites in Saudi Arabia.
Trial summary
This study is a randomized, open-label, parallel groups multi-centered trial were participants are assigned to either an intervention arm ( a combination of Favipiravir and Hydroxychloroquin) or standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19
- What is being tested?
- Favipiravir and Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 8 sitesSaudi Arabia
- Study dates
- 21 May 2020to 26 Apr 2021
- Phase
- Interventional
- 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
Who may be able to join
- Should be at least 18 years of age
- Male or nonpregnant female,
- Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection.
- Able to sign the consent form and agree to clinical samples collection (or their legal surrogates if subjects are or become unable to make informed decisions).
- Moderate or Severe COVID-19, defined as oxygen saturation (Sao2) of 94% or less while they were breathing ambient air or significant clinical symptoms with Chest X ray changes that require hospital admission.
- patients had to be enrolled within 10 days of disease onset
Who cannot join
- Patients who are pregnant or breastfeeding.
- Will be transferred to a non-study site hospital or expected to be discharged within 72 hours.
- Known sensitivity/allergy to hydroxychloroquine or Favipiravir
- Current use of hydroxychloroquine for another indication
- Prior diagnosis of retinopathy
- Prior diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Show all 15Show fewer
- Major comorbidities increasing the risk of study drug including: i. Hematologic malignancy, ii. Advanced (stage 4-5) chronic kidney disease or dialysis therapy, iii. Known history of ventricular arrhythmias, iv. Current use of drugs that prolong the QT interval, Severe liver damage (Child-Pugh score ≥ C, AST> 5 times the upper limit), HIV.
- The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues).
- Clinical prognostic non-survival, palliative care, or in deep coma and no have response to supportive treatment within three hours of admission.
- Patient with irregular rhythm
- Patient with a history of heart attack (myocardial infarction)
- Patient with a family history of sudden death from heart attack before the age of 50
- Take other drugs that can cause prolonged QT interval
- Patient who is receiving immunosuppressive therapy (cyclosporin) which cannot be switched to another agent or adjusted while using the investigational drug
- Gout/history of Gout or hyperuricemia (above the ULN), hereditary xanthinuria or xanthine calculi of the urinary tract.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Saudi Arabia8 sites
AlMadina General Hospital
Al Madīnah
Al-Qatif Central Hospital
Al Qaţīf
Imam Abdulrahman Al Faisal Hospital - Dammam
Dammam
King Abdulaziz Hospital - Al Ahsa
Hasa, Eastern Province
King Abdulaziz Medical City
Jeddah
King Abdulaziz Hospital - Makkah
Mecca
King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, 11426
Imam Abdulrahman Alfaisal Hospital
Riyadh
About this study
Official title: A Trial of Favipiravir and Hydroxychloroquine Combination in Adults Hospitalized With Moderate and Severe Covid-19
This study is a randomized, open-label, parallel groups multi-centered trial were participants are assigned to either an intervention arm ( a combination of Favipiravir and Hydroxychloroquin) or standard of care.
Read the detailed description
In this trial, the investigators want to evaluate the efficacy of the combination of Favipiravir and Hydroxychloroquine as potential therapy for moderate and severe cases with COVID -19. Favipiravir which is a new type of RNA-dependent RNA polymerase (RdRp) inhibitor has activity against influenza virus, and Hydroxychloroquine, an analogue of chloroquine, has a clinical safety profile better than that of chloroquine and allows higher daily dose, Chloroquine is a widely used antimalarial that was found to be a potential broad-spectrum antiviral.
There is an urgent need to explore therapeutic options for SARS-CoV-2 in order to face the pandemic. The selected combination was based on limited evidence clinically and in vitro on the efficacy of the Favipiravir and Hydroxychloroquine in SARS-CoV-2. The two medications were listed in many guidelines as treatment options and ongoing trials assessing their efficacy and safety. Thus, the investigators want to prove the effectiveness of the combination as therapy.
- Conditions
- COVID19
- Being tested
- Favipiravir and Hydroxychloroquine
- Keywords
- SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Favipiravir and HydroxychloroquineCombination product
Also called Avigan
Route of Administration: Oral (or through Nasogastric tube)
Dose:
Favipiravir: Administer 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (total days of therapy is 10 days or till hospital discharge)
Hydroxychloroquine (400mg) twice daily on day 1; for days 2-5 (200mg) twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Combination therapy Favipiravir (10 days) + Hydroxychloroquine(5 days) Receives: Combination Product: Favipiravir and Hydroxychloroquine |
| Control | No intervention | Standard of Care Treatment for COVID-19 Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement
The primary endpoint is the time to clinical improvement, defined as the time from the randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first.
Measured: 28 days
Secondary outcomes (1)
Viral shedding
PCR test negative conversion days from positive to negative.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start21 May 2020
- Primary completion26 Jan 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label, parallel groups were participants are assigned to either an intervention arm or standard of care.
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmad Alaskar, Study director, KAIMRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392973
- Sponsor's protocol ID
- RC20/174
- Acronym
- FACCT
- Status last verified
- Aug 2021
- First submitted
- 10 May 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosaeed M, Mahmoud E, Alharbi A, Altayib H, Albayat H, Alharbi F, Ghalilah K, Al Arfaj A, AlJishi J, Alarfaj A, Alqahtani H, Almutairi BM, Almaghaslah M, Alyahya NM, Bawazir A, AlEisa S, Alsaedy A, Bouchama A, Alharbi M, AlShamrani M, Al Johani S, Aljeraisy M, Alzahrani M, Althaqafi AO, Almarhabi H, Alotaibi A, Alqahtani N, Arabi YM, Aldibasi OS, Alaskar A. Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial. Infect Dis Ther. 2021 Dec;10(4):2291-2307. doi: 10.1007/s40121-021-00496-6. Epub 2021 Jul 28.
PubMed 34319552Bosaeed M, Mahmoud E, Hussein M, Alharbi A, Alsaedy A, Alothman A, Aljeraisy M, Alqahtani H, Nashabat M, Almutairi B, Almaghaslah M, Aldibasi O, AlJohani S, Bouchama A, Arabi Y, Alaskar A. A Trial of Favipiravir and Hydroxychloroquine combination in Adults Hospitalized with moderate and severe Covid-19: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 31;21(1):904. doi: 10.1186/s13063-020-04825-x.
PubMed 33129363
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Favipiravir and Hydroxychloroquine Combination in Adults Hospitalized With Moderate and Severe Covid-19
- ClinicalTrials.gov ID
- NCT04392973
- Acronym / sponsor ID
- FACCT / RC20/174
- Conditions
- COVID19
- Keywords
- SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 19 May 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.
This study is a randomized, open-label, parallel groups multi-centered trial were participants are assigned to either an intervention arm ( a combination of Favipiravir and Hydroxychloroquin) or standard of care.
Detailed description
In this trial, the investigators want to evaluate the efficacy of the combination of Favipiravir and Hydroxychloroquine as potential therapy for moderate and severe cases with COVID -19. Favipiravir which is a new type of RNA-dependent RNA polymerase (RdRp) inhibitor has activity against influenza virus, and Hydroxychloroquine, an analogue of chloroquine, has a clinical safety profile better than that of chloroquine and allows higher daily dose, Chloroquine is a widely used antimalarial that was found to be a potential broad-spectrum antiviral.
There is an urgent need to explore therapeutic options for SARS-CoV-2 in order to face the pandemic. The selected combination was based on limited evidence clinically and in vitro on the efficacy of the Favipiravir and Hydroxychloroquine in SARS-CoV-2. The two medications were listed in many guidelines as treatment options and ongoing trials assessing their efficacy and safety. Thus, the investigators want to prove the effectiveness of the combination as therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label, parallel groups were participants are assigned to either an intervention arm or standard of care.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Favipiravir and HydroxychloroquineCombination therapy Favipiravir (10 days) + Hydroxychloroquine(5 days) |
| Control | No intervention | –Standard of Care Treatment for COVID-19 Infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Should be at least 18 years of age
- Male or nonpregnant female,
- Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection.
- Able to sign the consent form and agree to clinical samples collection (or their legal surrogates if subjects are or become unable to make informed decisions).
- Moderate or Severe COVID-19, defined as oxygen saturation (Sao2) of 94% or less while they were breathing ambient air or significant clinical symptoms with Chest X ray changes that require hospital admission.
Key exclusion criteria (15 listed)
- Patients who are pregnant or breastfeeding.
- Will be transferred to a non-study site hospital or expected to be discharged within 72 hours.
- Known sensitivity/allergy to hydroxychloroquine or Favipiravir
- Current use of hydroxychloroquine for another indication
- Prior diagnosis of retinopathy
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 |
|---|---|---|
| Favipiravir and HydroxychloroquineAlso: AviganRoute of Administration: Oral (or through Nasogastric tube) Dose: Favipiravir: Administer 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (total days of therapy is 10 days or till hospital discharge) Hydroxychloroquine (400mg) twice daily on day 1; for days 2-5 (200mg) twice daily. | Combination product | Intervention |
Primary outcome
Clinical Improvement
Time frame: 28 days
The primary endpoint is the time to clinical improvement, defined as the time from the randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first.
1 secondary outcome
Viral shedding
Time frame: 28 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 20 Aug 2021.
- Derived from this study: PubMed 34319552Bosaeed M, Mahmoud E, Alharbi A, Altayib H, Albayat H, Alharbi F, Ghalilah K, Al Arfaj A, AlJishi J, Alarfaj A, Alqahtani H, Almutairi BM, Almaghaslah M, Alyahya NM, Bawazir A, AlEisa S, Alsaedy A, Bouchama A, Alharbi M, AlShamrani M, Al Johani S, Aljeraisy M, Alzahrani M, Althaqafi AO, Almarhabi H, Alotaibi A, Alqahtani N, Arabi YM, Aldibasi OS, Alaskar A. Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial. Infect Dis Ther. 2021 Dec;10(4):2291-2307. doi: 10.1007/s40121-021-00496-6. Epub 2021 Jul 28.
- Derived from this study: PubMed 33129363Bosaeed M, Mahmoud E, Hussein M, Alharbi A, Alsaedy A, Alothman A, Aljeraisy M, Alqahtani H, Nashabat M, Almutairi B, Almaghaslah M, Aldibasi O, AlJohani S, Bouchama A, Arabi Y, Alaskar A. A Trial of Favipiravir and Hydroxychloroquine combination in Adults Hospitalized with moderate and severe Covid-19: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 31;21(1):904. doi: 10.1186/s13063-020-04825-x.
- Individual participant dataSharing planned: No
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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.
Ahmad Alaskar study director
KAIMRC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Favipiravir and Hydroxychloroquine in people with COVID19, run by King Abdullah International Medical Research Center at 8 sites in Saudi Arabia.
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 6 inclusion and 15 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 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Saudi Arabia. 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 Improvement (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392973, which also lists 2 linked publications.
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 20 Aug 2021.