Clinical trial NCT04474340: COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients
Official title: COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients: Multicenter Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Moderate COVID-19 Pneumonia, Severe COVID-19 Pneumonia
Pneumonia, Viral
Keywords: convalescent plasma
respiratory infection
COVID-19
SARS-CoV-2
pneumonia
Lead sponsor: Ministry of Health, Kuwait
Sponsor class: OTHER_GOV
First posted: 2020-07-16
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Time to clinical improvement
timeFrame: 30 days
Secondary outcomes:
measure: All cause mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Ministry Of Health
Study officials:
affiliation: MOH
name: Sondus AlSharidah, MD
role: PRINCIPAL_INVESTIGATOR
References: