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

NCT04347681 | Completed Phase 2

• 1 other identifier: HAEM0321
• Study Type: interventional
• Target: 575
• Locations: 1 country
• Sites: 14

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.

Conditions

Convalescent Plasma for COVID 19

Outcome Measures

Primary Outcomes (2)

• ICU length of stay

  number of days in ICU

  Time from transfer into ICU to time of transfer out from ICU, Up to 12 weeks.

• Safety of convalescent plasma & Serious adverse reactions.

  reporting adverse events associated with transfusion as per transfusion medicine guidelines.

  time from signing consent to one month after transfusion, Up to 12 weeks.

Secondary Outcomes (3)

• Number of days on mechanical ventilation

  Time from intubation to time of extubation, Up to 12 weeks.

• 30 days of mortality

  30 days from signing consent Up to 12 weeks.

• Days to clinical recovery .

  time from signing consent to recovery,Up to 12 weeks.

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

convalescent plasma from recovered COVID 19 donor OTHER

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).
• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Fahad Specialist Hospital Dammam: lead
• King Fahad Medical City: collaborator
• King Faisal Specialist Hospital & Research Center: collaborator
• King Abdulaziz Medical City: collaborator
• King Fahad University Hospital: collaborator
• John Hopkins Aramco Healthcare: collaborator
• Taibah University: collaborator
• King Saud University: collaborator
• King Khaled University Hospital: collaborator
• King Fahad Military Medical Complex: collaborator
• Qatif Central Hospital: collaborator

Study Sites (14)

John Hopkins Aramco Healthcare

Dhahran, Eastern Provence, Saudi Arabia

Location

Qatif Central Hospital

Al Qaţīf, Saudi Arabia

Location

Dammam Medical Complex

Dammam, Saudi Arabia

Location

Imam Abdulrahman Bin Faisal University

Dammam, Saudi Arabia

Location

king Fahad specialist hospital

Dammam, Saudi Arabia

Location

DHahran Military Medical Complex

Dhahran, Saudi Arabia

Location

International Medical Center

Jeddah, Saudi Arabia

Location

Madinah General Hospital

Madinah, Saudi Arabia

Location

Ohud Hospital

Madinah, Saudi Arabia

Location

Taibah University

Madinah, Saudi Arabia

Location

King Abdulaziz Medical City

Riyadh, Saudi Arabia

Location

King Fahad Medical City

Riyadh, Saudi Arabia

Location

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

Location

King Khalid University Hospital

Riyadh, Saudi Arabia

Location

Related Publications (2)

• AlShehry N, Zaidi SZA, AlAskar A, Al Odayani A, Alotaibi JM, AlSagheir A, Al-Eyadhy A, Balelah S, Salam A, Zaidi ARZ, Alawami D, Alshahrani MS, AlMozain N, Abulhamayel YM, Al Qunfoidi R, Alfaraj M, Qushmaq N, Alansari R, Dayel A, Elgohary G, Al Bahrani A, Nabhan Abdelhameed AA, AlZahrani HA, Alturkistani H, AlShehry N, Albalawi MA, Elalfy I, Alhumaidan H, Al-Hashmi H; KSA COVID-19 Convalescent Plasma Study Group. Safety and Efficacy of Convalescent Plasma for Severe COVID-19: Interim Report of a Multicenter Phase II Study from Saudi Arabia. Saudi J Med Med Sci. 2021 Jan-Apr;9(1):16-23. doi: 10.4103/sjmms.sjmms_731_20. Epub 2020 Dec 26.

  PMID: 33519339 DERIVED

• Albalawi M, Zaidi SZA, AlShehry N, AlAskar A, Zaidi ARZ, Abdallah RNM, Salam A, AlSagheir A, AlMozain N, Elgohary G, Batarfi K, Alfaraedi A, Khojah O, Al-Ansari R, Alfaraj M, Dayel A, Al Bahrani A, Abdelhameed AN, Alhumaidan H, Al-Otaibi JM, Radwi G, Raizah A, Shatry H, Alsaleh S, AlZahrani H, Al-Hashmi H. Safety and Efficacy of Convalescent Plasma to Treat Severe COVID-19: Protocol for the Saudi Collaborative Multicenter Phase II Study. JMIR Res Protoc. 2020 Oct 2;9(10):e23543. doi: 10.2196/23543.

  PMID: 32903199 DERIVED

Study Officials

• Hani Al-Hashmi, MD

  King Fahad Specialist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: experimental arm receiving convalescent plasma and parallel arm is control.

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2020
• Study Start: April 18, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 16, 2020
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (14)