Clinical Trial For Early SARS-CoV-2 (COVID-19) Treatment
NCT ID: NCT04981379
Last Updated: 2021-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1120 participants
INTERVENTIONAL
2020-11-16
2021-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Hydroxychloroquine + Favipiravir
Hydroxychloroquine 2x200 mg 5 days and favipiravir 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days)
Favipiravir + Hydroxychloroquine
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.
Favipiravir + Placebo (Hydroxychloroquine)
Favipiravir 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days) + Placebo (Hydroxychloroquine ) 2x200 mg (5 days)
Favipiravir
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.
Hydroxychloroquine + Placebo (Favipiravir)
Hydroxychloroquine 2x200 mg (for 5 days) + placebo (favipiravir) 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days)
Hydroxychloroquine
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.
Placebo (Favipiravir) + Placebo (Hydroxychloroquine)
Placebo (favipiravir) 2 x 1600 mg loading, then 4 days 2 x 600 mg maintenance (5 days) + Placebo (Hydroxychloroquine) 2x200 mg (5 days)
Placebo
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.
Interventions
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Hydroxychloroquine
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.
Favipiravir
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 + Hydroxychloroquine
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.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients between 18-60 years old.
3. Patients whose symptoms and complaints associated with COVID-19 started within 48 hours.
4. Mild cases whose treatment to be given as outpatient.
1. Although asymptomatic, patients with high CRP (\> 20 mg/L) and/or lymphopenia (\<1000/mm3)
2. Patients with symptoms such as fever, muscle/joint pain, cough, sore throat, nasal congestion, loss of smell.
3. Patients without serious underlying diseases (cardiovascular diseases, diabetes mellitus, hypertension, cancer, chronic lung diseases, immunosuppressive conditions)
4. Patients with normal chest x-ray and / or chest tomography (no sign of pneumonia)
5. Patients who accept oropharyngeal sample and venous blood collection at regular intervals within the scope of the protocol.
6. Patients who were not involved in any other interventional study.
Exclusion Criteria
2. Being under the age of 18 and over the age of 60.
3. Patients with a known history of allergy to one of the study drugs (hydroxychloroquine, favipiravir).
4. Volunteers who the researcher thinks may have problems with adherence to treatment.
5. Volunteers who will have trouble taking medication by mouth due to resistant nausea, vomiting or chronic diarrhea.
6. Patients with chronic liver disease and transaminase (ALT or AST) levels 5 times the higher than the normal level.
7. Patients with heart disease or arrhythmia history.
8. Patients with gout or hyperuricemia.
9. Patients with signs of pneumonia in their lungs.
10. Patients with chronic renal failure (glomerular filtration rate \<30).
11. Pregnant or breastfeeding patients.
18 Years
59 Years
ALL
No
Sponsors
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Health Institutes of Turkey
OTHER_GOV
Responsible Party
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Principal Investigators
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Ahmet Gül, Prof.
Role: STUDY_DIRECTOR
Faculty Member
Locations
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Ankara City Hospital
Ankara, , Turkey (Türkiye)
Başakşehir Çam ve Sakura City Hospital
Istanbul, , Turkey (Türkiye)
Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Istanbul University Istanbul Medicine Faculty
Istanbul, , Turkey (Türkiye)
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, , Turkey (Türkiye)
Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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COVID-19-FAV-HQ
Identifier Type: -
Identifier Source: org_study_id
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