Assessment of Safety and Efficacy of CCP

NCT04542941 | Completed DMC

• 1 other identifier: CCP
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Currently there are no proven treatments or vaccines for COVID-19 and care of the COVID patients is largely supportive involving treatment of symptoms such as fever with antipyretics, secondary bacterial chest infection with antibiotics and meticulous management of comorbid conditions. Several repurposed and new drugs have been investigated for treatment of COVID-19, however, none have been confirmed to be efficacious. These drugs include the antimalarials (chloroquine and hydroxychloroquine), antivirals such as remdesivir and favipiravir and antiretroviral combination therapies such lopinavir/ritonavir. There is emerging evidence to support the use of COVID convalescent plasma for the treatment of COVID-19. There is need to leverage the blood transfusion services in countries and this is beginning to happen on the continent.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Time to viral clearance (RT-PCR negativity)

  The primary end point will be time to viral clearance (RT-PCR negativity).

  28 days

Secondary Outcomes (3)

• Time to symptom resolution

  28 days

• Time to severe/critical disease

  28 days

• Number of participants reporting an adverse event as evidenced by clinical manifestations

  28 days

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

The participants will receive COVID Convalescent Plasma in addition to the standard of care received by all COVID 19 patients

Biological: COVID Convalescent Plasma

Control arm

NO INTERVENTION

The participants under this arm will receive the COVID 19 standard of care

Interventions

COVID Convalescent Plasma BIOLOGICAL

Plasma collected from recovered COVID 19 individuals

Intervention arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with documented laboratory RT PCR confirmed SAR-CoV-2 infection
• Patients able to provide informed consent. In the event that the patient cannot provide consent e.g. they are severely sick, the next of kin or legal surrogate decision make

You may not qualify if:

• Prior diagnosis of IgA deficiency
• Inability to return for post discharge follow up

Sponsors & Collaborators

• Makerere University: lead
• Uganda Blood Transfusion Services: collaborator
• Joint Clinical Research Center: collaborator
• Uganda Peoples Defence Forces Medical Services: collaborator
• Mulago Hospital, Uganda: collaborator

Study Sites (1)

Mulago Specialised Hospital

Kampala, 256, Uganda

Location

Related Publications (1)

• Kirenga B, Byakika-Kibwika P, Muttamba W, Kayongo A, Loryndah NO, Mugenyi L, Kiwanuka N, Lusiba J, Atukunda A, Mugume R, Ssali F, Ddungu H, Katagira W, Sekibira R, Kityo C, Kyeyune D, Acana S, Aanyu-Tukamuhebwa H, Kabweru W, Nakwagala F, Bagaya BS, Kimuli I, Nantanda R, Buregyeya E, Byarugaba B, Olaro C, Mwebesa H, Joloba ML, Siddharthan T, Bazeyo W. Efficacy of convalescent plasma for treatment of COVID-19 in Uganda. BMJ Open Respir Res. 2021 Aug;8(1):e001017. doi: 10.1136/bmjresp-2021-001017.

  PMID: 34376401 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a prospective randomized two arm open label clinical trial. Patients with confirmed COVID-19 who meet the study eligibility criteria will be randomized to receive either CCP in addition to standard of care therapy or standard of care therapy alone.

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 9, 2020
• Study Start: June 16, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)