Clinical Trials Logo

Clinical Trial Summary

This is an double-blind, randomized, placebo controlled phase III study in hospitalized subjects with confirmed SARS-CoV-2.


Clinical Trial Description

Recruitment SSubjects hospitalised or attended the hospital ED with a confirmed diagnosis of SARS-CoV-2, will be contacted. Potential subjects will have the opportunity to ask any questions to the researchers. A member of the research team will provide a copy of the information sheet to the subject, who will have the opportunity to ask any questions to the researchers. Subjects expressing an interest in participating will be interviewed to explain the study in detail, and discuss the risks, benefits, goals and limitations of the study. Screening Procedures. Potentially eligible subjects will provide informed consent prior to any study specific procedures being conducted. Following the provision of informed consent, the subject's demographics and medical history especially that relating to SARS-CoV-2 will be documented. A physical examination and checks on vital signs (BP, pulse, temperature, respiration) will be conducted. Female subjects of child-bearing potential will undergo a urine pregnancy test. A blood sample will be drawn for routine haematology and biochemistry. Subjects will undergo tests for oxygen saturation, PaO2/FiO2 and interleukin-6 (IL-6). Subjects will be asked to provide details of any concomitant medications. Subjects with confirmed diagnosis of SARS-CoV-2, compliance with the inclusion and exclusion criteria and providing informed consent will be registered on the e-CRF to obtain a randomisation number. Baseline/Randomisation A physical examination and checks on vital signs (BP, pulse, temperature, respiration) will be conducted. Subjects will undergo tests for oxygen saturation, PaO2/FiO2 and interleukin-6. Haematology and biochemistry test (from screening) results will be confirmed as being acceptable. The study centre will dispense the IMP under blinded conditions according to a permuted block randomisation sequence (1:1 ratio for the two subject groups). The subjects will be trained on the dosing and asked to administer two capsules twice daily for 4 weeks. Subjects will then be provided with IMP on a daily basis by a suitably qualified and delegated member of the Investigator's team, for the duration of the treatment phase. Treatment Phase (Week 1-3) All subjects will receive standard of care treatment throughout the treatment phase on a day to day basis. This will include assessment of additional or alternative medication required for the treatment of SARS-CoV-2, requirement for intubation and invasive ventilation, requirement to transfer to intensive care unit or death. On a weekly basis, a physical examination and checks on vital signs (BP, pulse, temperature, respiration) will be conducted. Subjects will undergo tests for oxygen saturation, PaO2/FiO2 and IL-6. Subjects will be asked to provide details of any concomitant medications and changes in condition via adverse event (AE) query. Week 4 A physical examination and checks on vital signs (BP, pulse, temperature, respiration) will be conducted. Subjects will undergo tests for oxygen saturation, PaO2/FiO2 and IL-6. Female subjects of child-bearing potential will undergo a urine pregnancy test. A blood sample will be drawn for routine haematology and biochemistry. Subjects will be asked to provide details of any concomitant medications and changes in condition via AE query. Week 6 (Follow -up) 6 weeks after randomisation (or two weeks after early withdrawal), the subject will be contacted to check the occurrence of any other adverse events and review of medications. Haematology and biochemistry test (from week 4) results will be confirmed as being acceptable. Adverse events will be assessed by spontaneous reports by subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04335032
Study type Interventional
Source S.L.A. Pharma AG
Contact Justin Slagel
Phone 01923681001
Email jslagel@slapharma.com
Status Recruiting
Phase Phase 3
Start date January 8, 2021
Completion date December 1, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04527471 - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT05584202 - Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants Phase 2
Completed NCT04579549 - Repeat Testing for SARS-CoV-2 N/A
Active, not recruiting NCT05547243 - A Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants in China N/A
Recruiting NCT04613310 - PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19) N/A
Recruiting NCT04747574 - Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection Phase 1
Terminated NCT04447404 - DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury Phase 2
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Withdrawn NCT04388709 - Interferon Lambda Therapy for COVID-19 Phase 2
Active, not recruiting NCT05550142 - A Preliminary Exploratory Cohort Study of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in Participants Aged 18 Years and Over in China N/A
Completed NCT04620798 - Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students N/A
Active, not recruiting NCT05547256 - A Preliminary Exploratory Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants Aged 18 Years and Over in China N/A
Completed NCT04561102 - Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population
Completed NCT04452604 - Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Completed NCT05366322 - A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
Terminated NCT04958304 - Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study
Completed NCT04526769 - Detecting SARS-CoV-2 in Tears
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A