Status:
UNKNOWN
mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Repurposed Drugs (TACTIC-R)
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
COVID19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
TACTIC-R is a randomised, parallel arm, open-label platform trial for investigating potential treatment for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the firs...
Detailed Description
TACTIC-R will assess the efficacy of the immunomodulatory agents Baricitinib and Ravulizumab as potential treatments for COVID-19 disease against Standard of Care alone. These agents target the dysreg...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- To be included in the trial the participant must:
- Be aged 18 and over
- Have clinical picture strongly suggestive of COVID-19-related (with/without positive COVID-19 test) AND
- Risk count (as defined below) \>3 OR
- ≥ 3 if risk count includes "Radiographic severity score \>3"
- Be considered an appropriate subject for intervention with immunomodulatory in the opinion of the supervising clinician
- Be able to be maintained on venous thromboembolism prophylaxis or current maintenance therapy during inpatient dosing period, according to local guidelines
- Exclusion Criteria
- The presence of any of the following will preclude participant inclusion:
- Inability to supply direct informed consent or assent from Next of Kin or Independent Healthcare Provider on behalf of patient
- Mechanical ventilation at time of prior to dosing
- Contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients
- Currently on any of the study investigational medicinal products
- Known unresolved Neisseria meningitidis infection
- Unwilling to be vaccinated against Neisseria meningitidis or receive prophylactic antibiotic cover until 2 weeks after vaccination
- Known active tuberculosis (no blood screening required)
- Known active Hepatitis B or C (no blood screening required); active varicella zoster
- Concurrent participation in any interventional clinical trial including COVID-19-related disease trials (observational studies allowed)
- Patient moribund at presentation or screening
- Pregnancy at screening (or unwillingness to adhere to pregnancy advice in protocol)
- Unwillingness to adhere to breastfeeding advice in protocol
- Either alanine transaminase or aspartate transaminase (ALT or AST) \> 5 times the upper limit of normal
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. Cockcroft Gault estimated creatinine clearance \< 30 ml /min/1.73 m\^2)
- Currently receiving probenecid or chronic IVIG treatment
- Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern.
- Risk Count
- Patients will be given a Risk Count equal to the cumulative points received for the following criteria (no = 0 points, yes = 1 point):
- Male gender, Age \> 40 years, Non-white ethnicity, Diabetes, Hypertension, Neutrophils \> 8.0x10\^9/L, CRP \> 40mg/L, Radiographic severity score \>3
Exclusion
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
1167 Patients enrolled
Trial Details
Trial ID
NCT04390464
Start Date
May 8 2020
End Date
May 1 2022
Last Update
May 18 2020
Active Locations (1)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ