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Potential Efficacy of Convalescent Plasma to Treat Severe COVID-19 and Patients at High Risk of Developing Severe COVID-19

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ClinicalTrials.gov Identifier: NCT04347681
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborators:
King Fahad Medical City
King Faisal Specialist Hospital And Research Center
King Abdulaziz Medical City
King Fahad University Hospital
John Hopkins Aramco Healthcare
Taibah University
King Saud University
King Khaled University Hospital
King Fahad Military Medical Complex
Qatif Central Hospital
Information provided by (Responsible Party):
King Fahad Specialist Hospital Dammam

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 (ICU) support to survive as its lethality increases with the increasing age. Development of a vaccine by pharmaceutical companies like Roche and antibody concentrates from convalescent patients' plasma by Takeda will take 10-12 months to complete, and we speculate that it will be overwhelmingly expensive and limited in supply. We are presenting this urgent proposal to use the convalescent plasma to save the lives of severely affected COVID-19 patients. Most of the logistic support is already available in MOH Saudi Arabia, and it will be a cheap and quick technique based on the time-tested principles of passive immunization which is supported by the most recent data from China. We are proposing to test the therapeutic potential of convalescent plasma (from patients who have fully recovered from COVID-19) in treating patients with serious COVID-19 disease or those who are at risk of developing a serious disease based on their comorbidities profile. Convalescent plasma could provide our first-line defense for people with Covid-19, especially those who are older and at a much higher risk for complications. Amid the COVID-19 pandemic, with no available vaccine or proven antiviral drug, antibodies from recovering patients could provide a "stopgap" measure to help in controlling the pandemic effects on health and economy.

We plan to recruit at least 40 consenting donors and patients. Non-consenting patients will serve as controls.


Condition or disease Intervention/treatment Phase
Convalescent Plasma for COVID 19 Other: convalescent plasma from recovered COVID 19 donor Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 575 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: experimental arm receiving convalescent plasma and parallel arm is control.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A National Collaborative Multicenter Phase II Study for Potential Efficacy of Convalescent Plasma to Treat Severe COVID-19 and Patients at High Risk of Developing Severe COVID-19
Actual Study Start Date : April 18, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 11, 2021

Arm Intervention/treatment
Experimental: Treatment Group
We are aiming to include 40 patients (recipients) who have COVID 19 but have not recovered yet as per the inclusion criteria.
Other: convalescent plasma from recovered COVID 19 donor
After obtaining informed consent, Eligible Patients who have severe COVID-19 and have not recovered yet will be infused with the donated convalescent plasma (10-15 ml/kg body weight of recipient)19 at least once & if possible, daily, for up to 5 sessions.

No Intervention: control group
Patients who only consent for sharing their clinical and laboratory data will serve as a control group to compare the efficacy of the convulsant plasma. Age and sex matched historical control could be used if need.



Primary Outcome Measures :
  1. ICU length of stay [ Time Frame: Time from transfer into ICU to time of transfer out from ICU, Up to 12 weeks. ]
    number of days in ICU

  2. Safety of convalescent plasma & Serious adverse reactions. [ Time Frame: time from signing consent to one month after transfusion, Up to 12 weeks. ]
    reporting adverse events associated with transfusion as per transfusion medicine guidelines.


Secondary Outcome Measures :
  1. Number of days on mechanical ventilation [ Time Frame: Time from intubation to time of extubation, Up to 12 weeks. ]
    number of days patient spend on ventilator.

  2. 30 days of mortality [ Time Frame: 30 days from signing consent Up to 12 weeks. ]
    the death rate in 30 days after signing consent

  3. Days to clinical recovery . [ Time Frame: time from signing consent to recovery,Up to 12 weeks. ]
    number of days to symptoms resolution and COVID 19 negative PCR ( by NP swap)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:s

  1. 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 ).

    1. 18 or older
    2. Patient with COVID 19 confirmed as per case definition of CDC or MOH/Waqayah
    3. Must have been requiring ICU care or severe or immediately life-threatening care:

    i. Patient requiring ICU admission. ii. Severe disease is defined as:

    1. Dyspnea
    2. Respiratory frequency ≥ 30/min
    3. Blood oxygen saturation ≤ 93%
    4. 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:
    1. Respiratory failure
    2. Septic shock, and/or
    3. Multiple organ dysfunction or failure
  2. Donors:

    1. 18 or older
    2. 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
    3. Complete Clinical Recovery from COVID-19 at least 14 days prior to donation (FDA IND guidance15)
    4. All MOH criteria for a fit donor will be followed prior to donation.
    5. All Transfusion Transmissible Infections (TTI) markers on the donor blood are negative as per current MOH routine donor screening regulations

Exclusion Criteria:

  1. Recipients:

    1. Negative or non-conclusive test COVID-19 rRT PCR test for SARS-CoV-2
    2. Mild symptoms
    3. Hospitalization not requiring ICU admission
  2. Donors:

    1. Unfit to donate.
    2. Multiparous or pregnant females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347681


Contacts
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Contact: Hani AL-Hashmi, MD 00966564773377 hanih.hashmi@kfsh.med.sa
Contact: Mahammad Awadallah, MSc 00966545032312 mahammad.awadalla@kfsh.med.sa

Locations
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Saudi Arabia
John Hopkins Aramco Healthcare Recruiting
Dhahran, Eastern Provence, Saudi Arabia
Contact: Yem Abulhamayel, MD         
Principal Investigator: Yem Abulhamayel, MD         
Sub-Investigator: Ahmed Alsagheir, MD         
Dammam Medical Complex Recruiting
Dammam, Saudi Arabia
Contact: Ibrahim Elafi, MD       ielalfi@moh.gov.sa   
Principal Investigator: Ibrahim Elafi, MD         
Imam Abdulrahman Bin Faisal University Not yet recruiting
Dammam, Saudi Arabia
Contact: Muhammad Al Shahrani, MD         
Sub-Investigator: Arwa Nabhan, MD         
Principal Investigator: Muhammad Al Shahrani, MD         
king Fahad specialist hospital Recruiting
Dammam, Saudi Arabia
Principal Investigator: Hani Al-Hashmi, MD         
Sub-Investigator: Afra Al-Dayel, MD         
Sub-Investigator: Ahmed Albahrani, MD         
DHahran Military Medical Complex Not yet recruiting
Dhahran, Saudi Arabia
Contact: Rehab Al-Ansari, MD         
Principal Investigator: Rehab Al-Ansari, MD         
International Medical Center Recruiting
Jeddah, Saudi Arabia
Contact: Reem Alqunfoidi, MD    00966556036330    rqunfoidi@gmail.com   
Principal Investigator: Reem Alqunfoidi, MD         
Madinah General Hospital Recruiting
Medina, Saudi Arabia
Contact: Saud Balilah, MD       sbalelah@moh.gov.sa   
Principal Investigator: Saud Balilah, MD         
Ohud Hospital Recruiting
Medina, Saudi Arabia
Contact: Saud Balilah, MD       sbalelah@moh.gov.sa   
Principal Investigator: Saud Balilah, MD         
Taibah University Not yet recruiting
Medina, Saudi Arabia
Contact: Mohammed Albalawi, MD         
Principal Investigator: Mohammed Albalawi, MD         
Qatif Central Hospital Recruiting
Qatif, Saudi Arabia
Contact: Mona Alfaraj, MD         
Principal Investigator: Mona Alfaraj, MD         
King Abdulaziz Medical City Recruiting
Riyadh, Saudi Arabia
Contact: Ahmed Al Askar, MD         
Principal Investigator: Ahmed Al Askar, MD         
King Fahad Medical City Recruiting
Riyadh, Saudi Arabia
Contact: Nawal AlShehry, MD         
Principal Investigator: Nawal AlShehry, MD         
Sub-Investigator: Syed Zaidi, MD         
Sub-Investigator: Abdul Rehman Zaidi, MD         
Sub-Investigator: Rania Abdallah, MD         
Sub-Investigator: Imran Pukhta, MD         
Sub-Investigator: Tariq M Sulaiman, MD         
King Faisal Specialist Hospital & Research Center Recruiting
Riyadh, Saudi Arabia
Contact: Jawaher AlOtaibi, MD         
Principal Investigator: Jawaher AlOtaibi, MD         
Sub-Investigator: Hazza AlZahrani, MD         
Sub-Investigator: Hind Alhumaidan, MD         
King Khalid University Hospital Not yet recruiting
Riyadh, Saudi Arabia
Contact: Ayman Aleyadhy, MD         
Sub-Investigator: Nour AlMozain, MD         
Sub-Investigator: Alia Alfraedhi, MD         
Principal Investigator: Ayman Aleyadhy, MD         
Sub-Investigator: Ghada Elgohary, MD         
Sub-Investigator: Osamah Khojah, MD         
Sponsors and Collaborators
King Fahad Specialist Hospital Dammam
King Fahad Medical City
King Faisal Specialist Hospital And Research Center
King Abdulaziz Medical City
King Fahad University Hospital
John Hopkins Aramco Healthcare
Taibah University
King Saud University
King Khaled University Hospital
King Fahad Military Medical Complex
Qatif Central Hospital
Investigators
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Principal Investigator: Hani Al-Hashmi, MD King Fahad Specialist Hospital
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King Fahad Specialist Hospital Dammam
ClinicalTrials.gov Identifier: NCT04347681    
Other Study ID Numbers: HAEM0321
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No