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

COVID Clinical Trial

— CCAP  

Official title:

Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04345289
• Other study ID #: 25032020
• Secondary ID: 2020-001367-88
• Status: Terminated
• Phase: Phase 3
• Start date: May 1, 2020
• Est. completion date: March 16, 2021

Study information

• Verified date: August 2022
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 147
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID
• Pneumonia
• Pneumonia, Viral
• Viral Pneumonia

Intervention

Biological:
• Convalescent anti-SARS-CoV-2 plasma
Single infusion of convalescent anti-SARS-CoV-2 plasma (2 x 300 mL)

Other:
• Infusion placebo
Saline 0.9% (600 ml) as an iv single dose infusion

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Arhus
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Gentofte Hospital	Herlev
Denmark	Herning Hospital	Herning
Denmark	Nordsjællands Hospital	Hillerød
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Kolding Hospital	Kolding
Denmark	Odense University Hospital	Odense
Denmark	Roskilde Hospital	Roskilde
Denmark	Vejle Hospital	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Benfield

Country where clinical trial is conducted

Denmark, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality or need of invasive mechanical ventilation	Composite outcome	28 days
Secondary	Frequency of adverse events	Number of participants with adverse events with possible relation to study drug	90 days
Secondary	Frequency of severe adverse events	Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines	90 days
Secondary	Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status	Number of days to improvement of at least 2 categories relative to baseline on the ordinal scale. Categories are as follows: Death; Hospitalized, in intensive care requiring Extracorporeal Membrane Oxygenation (ECMO) or mechanical ventilation; Hospitalized, on non-invasive ventilation or high-flow oxygen device; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities	90 days
Secondary	Ventilator-free days	Number of days without mechanical ventilation	28 days
Secondary	Organ failure-free days	Number of days without organ-failure	28 days
Secondary	Duration of ICU stay	Number of days in ICU	90 days
Secondary	Mortality rate	Number of deaths by any cause	7, 14, 21, 28 and 90 days
Secondary	Length of hospital stay	Days from the date of hospital admission for COVID-19 to the date of discharge	90 days
Secondary	Duration of supplemental oxygen	Days requiring supplement oxygen	90 days