Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia

• Status: Not yet recruiting
• Trial end date: 2021-06-15
• Target enrollment: 1500
• Participant gender: All

Summary

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled, multi-stage trial, which aims to assess the safety and efficacy of novel treatment option of moderate-severe COVID-19.

Participants will be randomized 1:1:1:1:1:1 to parallel treatment arms: Convalescent plasma, sarilumab, hydroxychloroquine, baricitinib, intravenous and subcutaneous placebo, or oral placebo.

Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Benfield
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• ≥18 years of age

• Confirmed COVID-19 infection by 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 <300 mmHg/40 kPa OR Radiographic findings compatible with COVID-19 pneumonia

• Onset of first experienced symptom, defined as one respiratory symptom or fever, no more than 10 days before admission

• For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period

• Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives

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 10⁹ /L); Alanine aminotransferase (ALT) greater than 5 x upper limit of normal (ULN); Platelet count <50,000 per mm3 (= 50 x 10⁹ /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