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Covid19Phase 3NCT04981379

Clinical Trial For Early SARS-CoV-2 (COVID-19) Treatment

A Phase 3 study testing Hydroxychloroquine, Favipiravir and Favipiravir + Hydroxychloroquine in people with Covid19, run by Health Institutes of Turkey at 6 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial which aims to investigate the superiority of hydroxychloroquine, favipiravir or hydroxychloroquine + favipiravir treatment, initiated especially in the early period in the treatment of COVID-19, over the patients being followed… Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Covid19
What is being tested?
Hydroxychloroquine, Favipiravir and Favipiravir + Hydroxychloroquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,120 participants
Where
6 sitesTurkey (Türkiye)
Study dates
16 Nov 2020to 16 Feb 2021
Phase
Phase 3
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 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Volunteers who have understood all the procedures to be applied within the scope of the study protocol and gave their consent.
  • Patients between 18-60 years old.
  • Patients whose symptoms and complaints associated with COVID-19 started within 48 hours.
  • Mild cases whose treatment to be given as outpatient.
  • Although asymptomatic, patients with high CRP (> 20 mg/L) and/or lymphopenia (<1000/mm3)
  • Patients with symptoms such as fever, muscle/joint pain, cough, sore throat, nasal congestion, loss of smell.
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  • Patients without serious underlying diseases (cardiovascular diseases, diabetes mellitus, hypertension, cancer, chronic lung diseases, immunosuppressive conditions)
  • Patients with normal chest x-ray and / or chest tomography (no sign of pneumonia)
  • Patients who accept oropharyngeal sample and venous blood collection at regular intervals within the scope of the protocol.
  • Patients who were not involved in any other interventional study.

Who cannot join

  • Patients who do not give their consent in writing after informing.
  • Being under the age of 18 and over the age of 60.
  • Patients with a known history of allergy to one of the study drugs (hydroxychloroquine, favipiravir).
  • Volunteers who the researcher thinks may have problems with adherence to treatment.
  • Volunteers who will have trouble taking medication by mouth due to resistant nausea, vomiting or chronic diarrhea.
  • Patients with chronic liver disease and transaminase (ALT or AST) levels 5 times the higher than the normal level.
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  • Patients with heart disease or arrhythmia history.
  • Patients with gout or hyperuricemia.
  • Patients with signs of pneumonia in their lungs.
  • Patients with chronic renal failure (glomerular filtration rate <30).
  • Pregnant or breastfeeding patients.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Turkey (Türkiye)6 sites

  • Ankara City Hospital

    Ankara

  • Başakşehir Çam ve Sakura City Hospital

    Istanbul

  • Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital

    Istanbul

  • Istanbul University Istanbul Medicine Faculty

    Istanbul

  • Kartal Dr. Lütfi Kırdar City Hospital

    Istanbul

  • Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Efficacy and Safety of the Use of Hydroxychloroquine, Favipiravir or Hydroxychloroquine + Favipiravir in Early SARS-CoV-2 (COVID-19) Treatment

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial which aims to investigate the superiority of hydroxychloroquine, favipiravir or hydroxychloroquine + favipiravir treatment, initiated especially in the early period in the treatment of COVID-19, over the patients being followed up with placebo in adults aged 18~59 Years.

Read the detailed description

This study is a randomized, double-blinded, and placebo controlled phase III clinical trial in in adults aged 18~59 Years. The study was planned as a multicenter, randomized controlled, double-blind, parallel-arm drug study. The purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine, favipiravir, or hydroxychloroquine + favipiravir treatments that were initiated early in patients who were caught during filiation or who were decided to be outpatient due to mild disease findings during hospital admission, after the diagnosis of COVID-19 against patients with placebo. It is planned that the study will be conducted with two separate arms. Study arms are planned as 2:2:2:1 for 320:320:320:160 patients as follows. The dose of Favipiravir has been determined as the standard dose. Hydroxychloroquine will also be given without a loading dose.

Conditions
Covid19
Being tested
Hydroxychloroquine, Favipiravir, Favipiravir + Hydroxychloroquine, Placebo
Keywords
COVID-19, Hydroxychloroquine, 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.

  • HydroxychloroquineDrug

    Also called Hydroxychloroquine sulfate

    Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval + Placebo [Favipiravir (1600 mg)], as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval.

  • FavipiravirDrug

    Also called Favicovir Film Tablet

    Favipiravir (1600 mg), as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Placebo [Hydroxychloroquine (200 mg)], as two tablets per day for 5-day interval.

  • Favipiravir + HydroxychloroquineDrug

    Also called Favicovir Film Tablet + Hydroxychloroquine sulfate

    Favipiravir (1600 mg), as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval.

  • PlaceboDrug

    Placebo [Favipiravir (1600 mg)], as two tablet per day at the first day and then Placebo Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval.

Study groups in NCT04981379
Study groupRoleWhat they receive
Hydroxychloroquine + FavipiravirActive comparatorHydroxychloroquine 2x200 mg 5 days and favipiravir 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days)
Receives: Drug: Favipiravir + Hydroxychloroquine
Favipiravir + Placebo (Hydroxychloroquine)Active comparatorFavipiravir 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days) + Placebo (Hydroxychloroquine ) 2x200 mg (5 days)
Receives: Drug: Favipiravir
Hydroxychloroquine + Placebo (Favipiravir)Active comparatorHydroxychloroquine 2x200 mg (for 5 days) + placebo (favipiravir) 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days)
Receives: Drug: Hydroxychloroquine
Placebo (Favipiravir) + Placebo (Hydroxychloroquine)Placebo comparatorPlacebo (favipiravir) 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days) + Placebo (Hydroxychloroquine) 2x200 mg (5 days)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Worsening of clinical findings

    Worsening of clinical findings such as respiratory distress or persistence of fever, which require hospital admission to begin another treatment (for example, remdesivir, dexamethasone, anti-cytokines, etc.)

    Measured: During the study

Secondary outcomes (13)

  1. Complete resolution of symptoms and signs

    Complete resolution of symptoms and signs

    Measured: Fifth day after examination

  2. Complete resolution of symptoms and signs

    Complete resolution of symptoms and signs

    Measured: Tenth day after examination

  3. Negative RT-PCR test for SARS-CoV-2

    Negative RT-PCR test for SARS-CoV-2 virus

    Measured: Tenth day after examination

  4. Determination of IgM, IgG levels for SARS-CoV-2

    Determination of IgM, IgG levels for SARS-CoV-2 virus

    Measured: Tenth day after examination

  5. Negative RT-PCR test for SARS-CoV-2

    Negative RT-PCR test for SARS-CoV-2 on the 30th day visit

    Measured: Thirtieth day after examination

  6. Determination of IgM, IgG antibodies

    Determination of IgM, IgG antibodies against SARS-CoV-2

    Measured: Thirtieth day after examination

  7. Development of signs of pneumonia

    Development of signs of pneumonia

    Measured: During the study

  8. Requirement of respiratory support with oxygen mask

    Requirement of respiratory support with oxygen mask

    Measured: During the study

  9. Requirement of respiratory support with high flow oxygen

    Requirement of respiratory support with high flow oxygen

    Measured: During the study

  10. Requirement of mechanical ventilation

    Requirement of mechanical ventilation

    Measured: During the study

  11. Death

    Death

    Measured: During the study

  12. The rate of discontinuation of treatments due to side effects

    The rate of discontinuation of treatments due to side effects (gastrointestinal, allergic skin rash, arrhythmia, other cardiac reasons)

    Measured: During the study

  13. Time to improvement of symptoms after the initiation of study drugs

    Time to improvement of symptoms after the initiation of study drugs

    Measured: During the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start16 Nov 2020
  3. Primary completion31 Jan 2021
  4. Study completion16 Feb 2021

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04981379
Sponsor's protocol ID
COVID-19-FAV-HQ
Status last verified
Jun 2021
First submitted
26 Jul 2021
Last updated
29 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McCullough PA. Favipiravir and the Need for Early Ambulatory Treatment of SARS-CoV-2 Infection (COVID-19). Antimicrob Agents Chemother. 2020 Nov 17;64(12):e02017-20. doi: 10.1128/AAC.02017-20. Print 2020 Nov 17.

    PubMed 32967849

  • Shrestha DB, Budhathoki P, Khadka S, Shah PB, Pokharel N, Rashmi P. Favipiravir versus other antiviral or standard of care for COVID-19 treatment: a rapid systematic review and meta-analysis. Virol J. 2020 Sep 24;17(1):141. doi: 10.1186/s12985-020-01412-z.

    PubMed 32972430

  • Doi Y, Hibino M, Hase R, Yamamoto M, Kasamatsu Y, Hirose M, Mutoh Y, Homma Y, Terada M, Ogawa T, Kashizaki F, Yokoyama T, Koba H, Kasahara H, Yokota K, Kato H, Yoshida J, Kita T, Kato Y, Kamio T, Kodama N, Uchida Y, Ikeda N, Shinoda M, Nakagawa A, Nakatsumi H, Horiguchi T, Iwata M, Matsuyama A, Banno S, Koseki T, Teramachi M, Miyata M, Tajima S, Maeki T, Nakayama E, Taniguchi S, Lim CK, Saijo M, Imai T, Yoshida H, Kabata D, Shintani A, Yuzawa Y, Kondo M. A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19. Antimicrob Agents Chemother. 2020 Nov 17;64(12):e01897-20. doi: 10.1128/AAC.01897-20. Print 2020 Nov 17.

    PubMed 32958718

  • Hu TY, Frieman M, Wolfram J. Insights from nanomedicine into chloroquine efficacy against COVID-19. Nat Nanotechnol. 2020 Apr;15(4):247-249. doi: 10.1038/s41565-020-0674-9.

    PubMed 32203437

  • Boulware DR, Pullen MF, Bangdiwala AS, Pastick KA, Lofgren SM, Okafor EC, Skipper CP, Nascene AA, Nicol MR, Abassi M, Engen NW, Cheng MP, LaBar D, Lother SA, MacKenzie LJ, Drobot G, Marten N, Zarychanski R, Kelly LE, Schwartz IS, McDonald EG, Rajasingham R, Lee TC, Hullsiek KH. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2020 Aug 6;383(6):517-525. doi: 10.1056/NEJMoa2016638. Epub 2020 Jun 3.

    PubMed 32492293

  • Kaptein SJF, Jacobs S, Langendries L, Seldeslachts L, Ter Horst S, Liesenborghs L, Hens B, Vergote V, Heylen E, Barthelemy K, Maas E, De Keyzer C, Bervoets L, Rymenants J, Van Buyten T, Zhang X, Abdelnabi R, Pang J, Williams R, Thibaut HJ, Dallmeier K, Boudewijns R, Wouters J, Augustijns P, Verougstraete N, Cawthorne C, Breuer J, Solas C, Weynand B, Annaert P, Spriet I, Vande Velde G, Neyts J, Rocha-Pereira J, Delang L. Favipiravir at high doses has potent antiviral activity in SARS-CoV-2-infected hamsters, whereas hydroxychloroquine lacks activity. Proc Natl Acad Sci U S A. 2020 Oct 27;117(43):26955-26965. doi: 10.1073/pnas.2014441117. Epub 2020 Oct 9.

    PubMed 33037151

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydroxychloroquine, Favipiravir and Favipiravir + Hydroxychloroquine in people with Covid19, run by Health Institutes of Turkey at 6 sites 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 10 inclusion and 11 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 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Worsening of clinical findings (time frame: During the study). 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 NCT04981379, which also lists 6 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 29 Jul 2021.

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