COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Plaquenil
Product Name: Plaquenil
Pharmaceutical Form: Tablet
CAS Number: 747-36-4
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Department of Infectious diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? =18 years of age ? Confirmed COVID-19 infection per WHO criteria / presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR) ? Evidence of pneumonia given by at least one of the following: ? SpO2 =93% on ambient air or PaO2/FiO2 =65 years) yes F.1.3.1 Number of subjects for this age range 750
Exclusion criteria
Exclusion criteria: ? In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment ? History of allergic reaction to study drug (as judged by the site investigator) ? Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor) ? Pregnant or breastfeeding, positive pregnancy test in a pre-dose examination or patients family planning within three months after receiving study agent ? Estimated glomerular filtration (eGFR) <30 ml/min ? Severe liver dysfunction (Child Pugh score C) ? Known history of the following medical conditions: ? Active or latent tuberculosis (TB) or history of incompletely treated TB ? Chronic hepatitis B or C infection ? Retinopathy or maculopathy ? Neurogenic hearing impairment ? Presence of any of the following abnormal laboratory values at screening: ? Absolute neutrophil count (ANC) less than 1000 mm3 (= 1,0 x 10? /L) ? Alanine aminotransferase (ALT) greater than 5 x upper limit of normal (ULN) ? Platelet count <50,000 per mm3 (= 50 x 10? /L) ? Immunosuppression, defined as following: ? Treatment with immunosuppressive agents, chemotherapy or immunomodulatory drugs within 30 days prior to inclusion ? Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisolone 20 mg or equivalent per day for 4 weeks ? Ongoing chemotherapy ? Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to evaluate the efficacy and safety of convalescent anti-SARS-CoV-2 plasma, hydroxychloroquine, sarilumab and baricitinib compared with placebo in combination with standard of care (SOC) for the treatment of moderate-to-severe COVID-19 pneumonia on the basis of the composite endpoint: All-cause mortality or need of invasive mechanical ventilation up to 28 days.;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is a composite endpoint: All-cause mortality or need of invasive mechanical ventilation up to 28 days.;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Frequency of adverse events ? Frequency of severe adverse events ? Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status ? Ventilator-free days to day 28 ? Organ failure-free days to day 28 ? Duration of ICU stay ? Mortality rate at days 7, 14, 21, 28, and 90 ? Length of hospital stay ? Duration of supplemental oxygen;Timepoint(s) of evaluation of this end point: See individual timepoints E.5.2. | — |
Countries
Denmark
Contacts
Public ContactCharlotte Kastberg Levin
Department of infectious diseases
Outcome results
None listed