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

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

Interventions

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.

Sponsors & Collaborators

• King Fahad Medical City

  collaborator OTHER_GOV

• King Faisal Specialist Hospital & Research Center

  collaborator OTHER

• King Abdulaziz Medical City

  collaborator OTHER_GOV

• King Fahad University Hospital

  collaborator UNKNOWN

• John Hopkins Aramco Healthcare

  collaborator UNKNOWN

• Taibah University

  collaborator OTHER

• King Saud University

  collaborator OTHER

• King Khaled University Hospital

  collaborator UNKNOWN

• King Fahad Military Medical Complex

  collaborator UNKNOWN

• Qatif Central Hospital

  collaborator OTHER

• King Fahad Specialist Hospital Dammam

  lead OTHER

Principal Investigators

• Hani Al-Hashmi, MD · King Fahad Specialist Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-18

Primary Completion

2020-11-01

Completion

2020-11-16

Countries

• Saudi Arabia

Study Locations