A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for Eurpean Union/United Kingdom SitesAdaptive COVID-19 Treatment Trial in the EU & UK (ACTT/EU/UK
- Conditions
- Influenza COVID-19MedDRA version: 20.0Level: HLTClassification code 10022005Term: Influenza viral infectionsSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001052-18-DK
- Lead Sponsor
- Regents of the University of Minnesota
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
1. Admitted to a hospital with synmptoms suggestive of COVID-19 infection
2. Subject (or legally authorised representative) provides informed consent prior to initiation of any study procedures
3. Subject (or legally authorised representative) understands and agrees to comply wiht planned study procedures
4.Male or non-pregnant female adult = 18 years of age at time of enrollment
5. Has laboratory - confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen as documented by either of the following: PCR positive in sample collected < 72 hours prior to randomisation OR PCR positive in sample collected = 72 hours prior to randomisation, documented inabilty to obtain a repeat sample (e.g. due to lack of testing supplies limited testing capacity, results taking > 24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection
6. Illness of any duaration, and at least one of the following:
Radiographic infiltrates by imagin (chest X-ray, CT-scanm etc.) OR SpO2 = 94% on room air, OR Requiring supplemental oxygen, OR Requiring mechanical ventilation or ECMO
7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not incluidng hormonal contraception from the time of screening through Day 29
8. Agrees to not participate in another clinical trial for treatment of COVID-19 or SARS-CoV-2 thorugh Day 29
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
1. ALT/AST > 5 times the upper limit of normal
2. Estimated glumerular filtration rate (eGFR) < 30 ml/min or patientes receiving hemodialysis or hemofiltration at time of screening
3. Neutropenia (absolute neutrophil count < 1000 cells/µL) (<1.0 x 103/µL, or <1.0 GI/L)
4. Lymphopenia (absolute lymphocyte count <200 cells/µL) (<0.20 x 103/µL or < 0.20 GI/L)
5. Pregnancy or breast feeding
6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours
7. Allergy to any study medication
8. Received three or more doses of remdesivir including the loadingdose, outside of the study under the EUA (or similar mechanism) for COVID-19
9. Received convalesent plasma or intravenous immunoglobulin (IVIg]) for COVID-19 the current ilness for which they are being enrolled
10. Received small molecule tyrosin kinase inhibitors (e.g. baricitinib, imatibib, genfinitib) in the 1 week prior to screening
11. Received monoclonal antibodies targeting cytokines (e.g. TNF inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab]) or cells (e.g. abatacept) im the 4 weeks prior to screening
12. Received moniclonal antibodies targeting B-cell (e.g. rituximab and including any targeting multiple cell lines including B-cells) in the 23 month prior to screening
13. Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with baricitinib is larger thatn the risk of COVID-19
14. Received = 20 mg/day of prednisolone or equivalent for =14 consecutive days in the 4 weeks prior to screening.
15. Use of probenecid that cannot be discontinued at study enrollment.
16. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
17. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
18. Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations is allowed for all subjects.
19. Have a history of VTE (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 12 weeks prior to screening or have a history of recurrent (>1) VTE (DVT/PE).
20. Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrollment, who, in the judgment of PI, are at increased risk for serious infections or other safety concerns given the study products.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method