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

Thomas Benfield

Status and phase: Terminated; Phase 3

Conditions: Corona Virus Infection; Viral Pneumonia; COVID

Treatments: Biological: Convalescent anti-SARS-CoV-2 plasma; Other: Infusion placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04345289

25032020

2020-001367-88 (EudraCT Number)

Details and patient eligibility

About

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19.

Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo.

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

Full description

The study is a randomized, double blinded, placebo-controlled, multicenter study with two parallel treatment arms consisting of either convalescent plasma or intravenous placebo. We plan to enroll a total of 1100 patients yielding a statistical power of 80 % to show a 30% relative reduction in risk of mechanical ventilation or death at day 28. Patients with confirmed COVID-19 infection and signs compatible with pneumonia will be enrolled in the study. The participants will be randomized 2:1 to the parallel treatment arms, and receive either single dose infusion treatment.

The primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days. Interim analysis will be performed frequently.

As new knowledge of treatment options for COVID-19 have emerged, the treatment arms including sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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
• 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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147 participants in 2 patient groups, including a placebo group

Convalescent plasma

Active Comparator group

Description:

Will receive active treatment with convalescent anti-SARS-CoV-2 plasma (600 ml) as a single dose iv infusion in addition to standard care.

Treatment:

Biological: Convalescent anti-SARS-CoV-2 plasma

Infusion placebo

Placebo Comparator group

Description:

Will receive placebo treatment with saline 0.9% (2 x 300 ml) as an iv single dose infusion in addition to standard care.

Treatment:

Other: Infusion placebo