COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients

Ministry of Health, Kuwait

Status and phase: Unknown; Phase 1

Conditions: Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia; Pneumonia, Viral

Treatments: Drug: COVID-19 Convalscent Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04474340

MOHKuwait

Details and patient eligibility

About

Due to the limitations of COVID-19 treatment and in the absence of licensed antiviral for COVID-19, the historical choice of therapeutic convalescent plasma (CP) is considered especially against RNA viruses .It was known that convalescent plasma does not only neutralize the pathogens but provide passive immunomodulatory properties that allows the recipient to control the exaggerated inflammatory cascade. However, still there is a lack of understanding of the mechanism of action of CCP therapeutic components. Reports from open label trials and case series show that CCP is safe and might be effective in severe cases with COVID-19 . Therefore, the World health organisation (WHO) and Food and Drug Administration (FDA) issued guidelines for the CCP usage and standardised the donor selection , which was further supported by Emergency use Authorisation (EUA) .

Therefore, the aim in the current study is to assess the effect of CCP on time to clinical improvement, hospital mortality and to evaluate the changes on oxygen saturation and laboratory markers (lymphocyte counts and C-reactive protein) compared with standard treatment alone in patients with moderate or severe COVID-19 disease.

Full description

This is a prospective multicenter interventional observational study will be conducted in 4 major tertiary hospitals (Al-Sabah, Farwaniya , Mubarak Al-Kabeer and Jahra) in Kuwait .

Enrollment: 300 estimated patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged ≥18 years old ( those who are younger are involved after case based discussion)
2. Confirmed laboratory diagnosis with SARS-CoV-2 ,and admission diagnosis of SARS-CoV-2.
3. Patients with moderate or severe COVID-19 (moderate COVID-19 disease defined as the presence of any signs of pneumonia (fever, cough, dyspnoea fast breathing) including SpO2 >90 on room air , but no signs of severe pneumonia (severe pneumonia have the above plus one of the following: respiratory rates >30 breaths/minutes or SpO2<90% on room air), or admission to intensive care unit (ICU) for respiratory support (i.e.high flow nasal cannula, non-invasive mechanical ventilation and intubation).

Exclusion criteria

1. -Contraindication to transfusion (volume overload, history of anaphylaxis to blood products).
2. • Patients presenting with acute severe multiorgan failure, hemodynamic instability.

3- Severe disseminated coagulopathy (DIC), septic shock and those with expected survival of less than 48 hours.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

CCP patients

Experimental group

Description:

1. Patient has to fulfil the inclusion/exclusion criteria of the ward or the ICU 2. Valid consent. 3. Request the CCP from the central blood bank (200-250 ml/dose - can be repeated again in 12 hours) this is through the local hospital blood bank. How to transfuse CCP: 1. Dose required is 200-250 ml/hr (one dose, can be repeated in 12 hrs), max total 500ml. 2. Premedication prior to administration of CCP (Acetaminophen, diphenhydramine,steriods) or according to hospital guidelines.

Treatment:

Drug: COVID-19 Convalscent Plasma

Control

No Intervention group

Description:

Standard COVID-19 treatment.