The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients
NCT ID: NCT04321616
Last Updated: 2020-04-14
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2/PHASE3
700 participants
INTERVENTIONAL
2020-03-28
2020-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Norwegian Coronavirus Disease 2019 Study
NCT04316377
"NORPLASMA" Covid-19 Convalescent Plasma Treatment Monitoring Study
NCT04463823
ACTIV-3: Therapeutics for Inpatients With COVID-19
NCT04501978
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
NCT04843761
MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
NCT05780463
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hydroxychloroquine
Remdesivir
Remdesivir will be given intravenously 100 mg daily for the duration of the hospitalization and up to 10 days total course. A loading dose of 200 mg at inclusion will be given.
(Standard of Care) SoC
The standard of care will be supplied to all patients not receiving a drug intervention.
Remdesivir
Hydroxychloroquine
Hydroxychloroquine will be given orally (in the ICU in gastrointestinal tubes) with 800 mg x 2 loading dose followed by 400 mg x 2 every day for a total of 10 days.
(Standard of Care) SoC
The standard of care will be supplied to all patients not receiving a drug intervention.
Control group - SoC
Hydroxychloroquine
Hydroxychloroquine will be given orally (in the ICU in gastrointestinal tubes) with 800 mg x 2 loading dose followed by 400 mg x 2 every day for a total of 10 days.
Remdesivir
Remdesivir will be given intravenously 100 mg daily for the duration of the hospitalization and up to 10 days total course. A loading dose of 200 mg at inclusion will be given.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hydroxychloroquine
Hydroxychloroquine will be given orally (in the ICU in gastrointestinal tubes) with 800 mg x 2 loading dose followed by 400 mg x 2 every day for a total of 10 days.
Remdesivir
Remdesivir will be given intravenously 100 mg daily for the duration of the hospitalization and up to 10 days total course. A loading dose of 200 mg at inclusion will be given.
(Standard of Care) SoC
The standard of care will be supplied to all patients not receiving a drug intervention.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Confirmed SARS-2-CoV-2 infection by PCR
3. Admitted to the hospital ward or the ICU
4. Subjects (or legally authorized representative) provides written informed consent prior to initiation of the study
Exclusion Criteria
2. (Aspartate Transaminase/ Alanine Aminotransferase) ASAT/ALAT \> 5 times the upper limit of normal
3. Acute co-morbidity within 7 days before inclusion such as myocardial infarction
4. Known intolerance to the available study drugs
5. Pregnancy, possible pregnancy or breast feeding
6. Any reason why, in the opinion of the investigators, the patient should not participate
7. Subject participates in a potentially confounding drug or device trial during the course of the study
8. Prolonged QT interval (\>450 ms)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oslo University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andreas Barratt-Due
Principal investigator, MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul Aukrust, MD, Professor
Role: STUDY_CHAIR
Oslo University Hospital
Andreas Barratt-Due, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Trine Kåsine, MD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Katerina Nezvalova-Henriksen, Pharm D, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo Hospital Pharmacies
Anne Margarita Dyrhol Riise, MD, Professor
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Marius Trøseid, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Inge Christoffer Olsen, PhD
Role: PRINCIPAL_INVESTIGATOR
NorCRIN
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Andreas Barratt-Due
Oslo, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Patrick-Brown TDJH, Barratt-Due A, Troseid M, Dyrhol-Riise AM, Nezvalova-Henriksen K, Kasine T, Aukrust P, Olsen IC; NOR Solidarity consortium. The effects of remdesivir on long-term symptoms in patients hospitalised for COVID-19: a pre-specified exploratory analysis. Commun Med (Lond). 2024 Nov 12;4(1):231. doi: 10.1038/s43856-024-00650-4.
Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.
Tveita A, Murphy SL, Holter JC, Kildal AB, Michelsen AE, Lerum TV, Kaarbo M, Heggelund L, Holten AR, Finbraten AK, Muller KE, Mathiessen A, Boe S, Fevang B, Granerud BK, Tonby K, Lind A, Dudman SG, Henriksen KN, Muller F, Skjonsberg OH, Troseid M, Barratt-Due A, Dyrhol-Riise AM, Aukrust P, Halvorsen B, Dahl TB, Ueland T; NOR-SOLIDARITY Consortium and the Norwegian SARS-CoV-2 Study Group Investigators. High Circulating Levels of the Homeostatic Chemokines CCL19 and CCL21 Predict Mortality and Disease Severity in COVID-19. J Infect Dis. 2022 Dec 13;226(12):2150-2160. doi: 10.1093/infdis/jiac313.
Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD014962. doi: 10.1002/14651858.CD014962.
Barratt-Due A, Olsen IC, Nezvalova-Henriksen K, Kasine T, Lund-Johansen F, Hoel H, Holten AR, Tveita A, Mathiessen A, Haugli M, Eiken R, Kildal AB, Berg A, Johannessen A, Heggelund L, Dahl TB, Skara KH, Mielnik P, Le LAK, Thoresen L, Ernst G, Hoff DAL, Skudal H, Kittang BR, Olsen RB, Tholin B, Ystrom CM, Skei NV, Tran T, Dudman S, Andersen JT, Hannula R, Dalgard O, Finbraten AK, Tonby K, Blomberg B, Aballi S, Fladeby C, Steffensen A, Muller F, Dyrhol-Riise AM, Troseid M, Aukrust P; NOR-Solidarity trial. Evaluation of the Effects of Remdesivir and Hydroxychloroquine on Viral Clearance in COVID-19 : A Randomized Trial. Ann Intern Med. 2021 Sep;174(9):1261-1269. doi: 10.7326/M21-0653. Epub 2021 Jul 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
118684
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.