COVID19Phase 1/2CP IN COVID19NCT04438694
Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
A Phase 1/2 study testing Convalescent Plasma in people with COVID19, run by Cairo University at 1 site in Egypt.
Trial summary
This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases. This Clinical trial is to be applied in Cairo University quarantine hospital. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID19
- What is being tested?
- Convalescent Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 31 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have laboratory confirmed COVID-19 and admitted to Cairo University isolation hospital.
- Admitted to acute care facility.
- Must have severe or immediately life-threatening COVID-19:
- Severe disease is defined as:
- dyspnea,
- respiratory frequency ≥ 30/min,
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- 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 (CT finding)
- Life-threatening disease is defined as:
- respiratory failure,
- septic shock, and/or
- multiple organ dysfunction or failure
Who cannot join
- Pregnancy
- Autoimmune disorder
- Participated in a CP trial in the past 6 months
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospital
Cairo
Mostafa ElShazly, MD PhD
Omar Fahmy, MD PhD
About this study
- This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases.
- This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank.
The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection.
Read more
An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP).
Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).
Read the detailed description
This study will be done inside Cairo university hospitals, it will involve a number of CP donors who were recovered from COVID-19 infection and were treated at Cairo University isolation hospital. The CP donation process will take place at CUH blood bank ,the number of the donors will be determined at the end of the study as it will vary according to the donation process .
The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo University isolation hospital.
- Conditions
- COVID19
- Being tested
- Convalescent Plasma, Standard of Care
- Keywords
- DONOR, RECIPIENT, CONVALESCENT PLASMA
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent PlasmaBiological
Convalescent Plasma
Standard of CareDrug
Standard of Care drugs administered as per Cairo University ICU protocol
| Study group | Role | What they receive |
|---|---|---|
| STANDARD OF COARE | Active comparator | Receiving SOC Receives: Drug: Standard of Care |
| STANDARD CP DOSE Adm (Two infusions) | Experimental | Two infusions 48 hours apart Receives: Biological: Convalescent Plasma; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalization/Recovery status
Decrease of hospital days of safety until discharge
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jun 2020
- Primary completion31 May 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study is a prospective, single-institution, single-arm, study using a historical control group for comparison. Open label, 2 arms: SOC and SOC+CP
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen El Desouky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438694
- Sponsor's protocol ID
- N39-2020
- Acronym
- CP IN COVID19
- Status last verified
- Sep 2020
- First submitted
- 16 Jun 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection
- ClinicalTrials.gov ID
- NCT04438694
- Acronym / sponsor ID
- CP IN COVID19 / N39-2020
- Conditions
- COVID19
- Keywords
- DONOR, RECIPIENT, CONVALESCENT PLASMA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases.
- This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank.
The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection.
An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP).
Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).
Detailed description
This study will be done inside Cairo university hospitals, it will involve a number of CP donors who were recovered from COVID-19 infection and were treated at Cairo University isolation hospital. The CP donation process will take place at CUH blood bank ,the number of the donors will be determined at the end of the study as it will vary according to the donation process .
The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo University isolation hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective, single-institution, single-arm, study using a historical control group for comparison. Open label, 2 arms: SOC and SOC+CP
| Arm | Type | Receives |
|---|---|---|
| STANDARD OF COARE | Active comparator | Drug: Standard of CareReceiving SOC |
| STANDARD CP DOSE Adm (Two infusions) | Experimental | Biological: Convalescent Plasma, Drug: Standard of CareTwo infusions 48 hours apart |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Must have laboratory confirmed COVID-19 and admitted to Cairo University isolation hospital.
- Admitted to acute care facility.
- Must have severe or immediately life-threatening COVID-19:
- dyspnea,
- respiratory frequency ≥ 30/min,
Key exclusion criteria (3 listed)
- Pregnancy
- Autoimmune disorder
- Participated in a CP trial in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Convalescent PlasmaConvalescent Plasma | Biological | STANDARD CP DOSE Adm (Two infusions) |
| Standard of CareStandard of Care drugs administered as per Cairo University ICU protocol | Drug | STANDARD CP DOSE Adm (Two infusions), STANDARD OF COARE |
Primary outcome
Duration of hospitalization/Recovery status
Time frame: 2-3 weeks
Decrease of hospital days of safety until discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Convalescent Plasma in people with COVID19, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nermeen ElDesouky, MD PhD (01006029006, nermeen.eldesoukey@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospitalization/Recovery status (time frame: 2-3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.