Status:
COMPLETED
Potential Efficacy of Convalescent Plasma to Treat Severe COVID-19 and Patients at High Risk of Developing Severe COVID-19
Lead Sponsor:
King Fahad Specialist Hospital Dammam
Collaborating Sponsors:
King Fahad Medical City
King Faisal Specialist Hospital & Research Center
Conditions:
Convalescent Plasma for COVID 19
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Coronavirus disease (COVID-19) pandemic has started to affect Saudi Arabia and is expected to cause a lot of morbidities and many patients, especially the elderly, will require intensive care unit (IC...
Detailed Description
Coronaviruses (CoV) are a large family of RNA viruses that cause illnesses ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Res...
Eligibility Criteria
Inclusion
- s
- Recipients:
- We will use the confirmed case definition of SARS-CoV-2 infection (COVID-19) with POSITIVE rRT PCR test for SARS-CoV-2 "using one of the SFDA approved kit used in KSA" as per current MOH / SCDPC (Waqayah) guidelines (derived from WHO and CDC ).
- 18 or older
- Patient with COVID 19 confirmed as per case definition of CDC or MOH/Waqayah
- Must have been requiring ICU care or severe or immediately life-threatening care:
- i. Patient requiring ICU admission. ii. Severe disease is defined as:
- Dyspnea
- Respiratory frequency ≥ 30/min
- Blood oxygen saturation ≤ 93%
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or Lung infiltrates \> 50% within 24 to 48 hours iii. Life-threatening disease is defined as:
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- Respiratory failure
- Septic shock, and/or
- Multiple organ dysfunction or failure
- Donors:
- 18 or older
- Recovery from Prior confirmed COVID-19 diagnosis through NEGATIVE rRT PCR test for SARS-CoV-2 from blood or nasopharyngeal swab - FDA IND guidance or the MOH updated recovery protocol 15.20.22.23
- Complete Clinical Recovery from COVID-19 at least 14 days prior to donation (FDA IND guidance15)
- All MOH criteria for a fit donor will be followed prior to donation.
- All Transfusion Transmissible Infections (TTI) markers on the donor blood are negative as per current MOH routine donor screening regulations
Exclusion
- Recipients:
- Negative or non-conclusive test COVID-19 rRT PCR test for SARS-CoV-2
- Mild symptoms
- Hospitalization not requiring ICU admission
- Donors:
- Unfit to donate.
- Multiparous or pregnant females.
Key Trial Info
Start Date :
April 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2020
Estimated Enrollment :
575 Patients enrolled
Trial Details
Trial ID
NCT04347681
Start Date
April 18 2020
End Date
November 16 2020
Last Update
November 16 2021
Active Locations (14)
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1
John Hopkins Aramco Healthcare
Dhahran, Eastern Provence, Saudi Arabia
2
Qatif Central Hospital
Al Qaţīf, Saudi Arabia
3
Dammam Medical Complex
Dammam, Saudi Arabia
4
Imam Abdulrahman Bin Faisal University
Dammam, Saudi Arabia