Coronavirus Disease (COVID-19)PRA-001NCT04348877
Plasma Rich Antibodies From Recovered Patients From COVID19
A study testing Antibody-Rich Plasma from COVID-19 recovered patients in people with Coronavirus Disease (COVID-19), run by Ain Shams University at 1 site in Egypt.
Trial summary
Prospective interventional study, single arm of purified convalescent plasma transfusion as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (75mg/12 hours for 5-10 days) and hydroxychroquine (400mg twice in first day, 200 twice for 4-9 days) ± Azithromycin 500mg daily for 5 days Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- What is being tested?
- Antibody-Rich Plasma from COVID-19 recovered patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2020to Dec 2020
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 -80 years old
- Must have laboratory confirmed COVID-19
- Must have severe or immediately life-threatening COVID-19, 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 Life-threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure
- Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative
Who cannot join
- Patient with mild or moderate COVID-19
- Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11556
About this study
Prospective interventional study, single arm of purified convalescent plasma transfusion as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (75mg/12 hours for 5-10 days) and hydroxychroquine (400mg twice in first day, 200 twice for 4-9 days) ± Azithromycin 500mg daily for 5 days
Read the detailed description
- Selection of donor according to the eligibility criteria
- Full medical history, concurrent medications, demographic data will be obtained.
- Complete clinical assessment with special emphasis on assessment of resolution of symptoms
- Body weight, height.
- A confirmatory diagnostic test result (e.g., nasopharyngeal swab) at the time of illness or serological test for SARS-CoV-2 antibodies after recovery will be collected
- COVID -19 PCR test by nasopharyngeal swab.
- Complete blood count with differential counts
- Viral screening (HBV, HCV, HIV \& Syphilis): Conventional testing by chemiluminescence followed by nucleic acid testing (NAT)
- Donor's written consent
- Plasma collection:
- Donor to be connected to microprocessor controlled plasmapheresis machine containing single use disposable kit for every donor.
- A certain amount of blood is withdrawn by pump from the patient and immediately anticoagulated then centrifuged in the machine.
- Blood components are separated into different layers according to the density of each component.
- The plasma layer is collected and diverted into the collection bag while all other components are infused back to the patient, thus ending the first cycle.
- Cycles are repeated until collecting a total of 400 ml of filtered plasma in the collection bag; that is one complete therapeutic dose for one patient in need.
- Pathogen reduction/Viral inactivation by the Solvent/Detergent (S/D) method:
- SD method is the gold standard for inactivation of enveloped viruses HBV, HCV and HIV. All these viruses have a lipid outer coat enveloping the nucleic acid.
- Tri-N Butyl Phosphate (TNBP) acts as an organic solvent to remove lipids from the membranes of pathogens.Tween-20 is a non-ionic detergent that stabilizes TNBP and disrupts lipid bilayers, thus easing the extraction of lipids. Since the solvent is toxic, it is removed using a sterile vegetable oil (Castor oil).
- Measuring remnants of TNBP:
- By chromatography in Ain Shams Toxicology Center.
- Concentration should be less than 10 ppm.
- Screening phase for patients selection:
- Obtaining informed consent: Written signed and dated informed consent will be obtained from each patient before being entered into the study. The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial. This will be obtained from each subject in accordance with the recommendation of the revised Declaration of Helsinki. The investigator will explain the nature, purpose and risks of the study. It will be clearly stated that the patient is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal. In case the patient is unable to provide his/her consent the legal guardian will give verbal approval on behaves of the patient and after he he/she will be well informed by the study design, procedure, risk and benefits over phone call. If it is difficult to reach the legal guardian, emergency approval will be obtained by Professional Legal Representative who will be the head authorities of the isolation hospital.
- Full medical history, concurrent medications, demographic data will be obtained.
- A thorough physical examination will be performed.
- Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and Blood oxygen saturation) will be recorded.
- Chest x-ray and CT scan for chest will be recorded
- Ventilation parameters to be recorded if ventilated
- Laboratory to perform the following tests: Complete blood count with differential counts, Renal function tests (RFTs) (serum creatinine), Liver function tests (LFTs) (alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin), Coagulation test; prothrombin time and INR and D.dimer, HIV Ab, HCV Ab and HBV surface antigen (HBsAg), COVID -19 PCR test by nasopharyngeal swab. Urine pregnancy test for females.
- Treatment phase for eligible patients:
- Eligibility confirmed
- Treatment with collected plasma in a dose of 400 ml on single therapeutic dose on Day1 as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (150mg/12 hours for 5-10 days) and hydroxychroquine (400mg twice in first day, 200 twice for 4-9 days) ± Azithromycin 500mg daily for 5 days.
- The patient's health status, and the presence of adverse events will be assessed daily
- Complete physical examination will be performed daily.
- Vital signs (blood pressure, heart rate and temperature) will be recorded.
- Follow-up CXR will be performed on daily and /CT scan will be performed as clinically indicated
- Coagulation test; prothrombin time and INR and D.dimer will be re-reassessed on day 3, 7, and 14
- HIV Ab, HCV Ab and HBV surface antigen (HBsAg) will be repeated at day 14
- COVID -19 PCR test by nasopharyngeal swab will be repeated every 72 hours.
- Post treatment period up to 30 days after end of treatment:
- Vital signs (blood pressure, heart rate and temperature) will be recorded.
- Symptoms and signs assessment will be done.
- Conditions
- Coronavirus Disease (COVID-19)
- Being tested
- Antibody-Rich Plasma from COVID-19 recovered patients
- Keywords
- Egypt
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibody-Rich Plasma from COVID-19 recovered patientsOther
400 millimeter of Antibody-Rich Plasma from COVID-19 recovered patients will be transfused to patients with severe or immediately life-threatening COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Antibody-Rich Plasma | Other | 400 millimeter of Antibody-Rich Plasma from COVID-19 recovered patients will be transfused to patients with severe or immediately life-threatening COVID-19 Receives: Other: Antibody-Rich Plasma from COVID-19 recovered patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
viral COVID-19 clearance
Two successive negative COVID-19 PCR analysis tests 72 hours apart
Measured: 14 days
Secondary outcomes (2)
Decrease of radiological abnormalities
The percentage of decrease of radiological abnormalities at day 14
Measured: 14 days
Clinical improvement
Clinical improvement in form of normal body temperature for 48 hours
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start20 Apr 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Antibody-Rich Plasma from COVID-19 recovered patients
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Fahmy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348877
- Sponsor's protocol ID
- FMASU P15/ 2020
- Acronym
- PRA-001
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 20 Apr 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 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Rich Antibodies From Recovered Patients From COVID19
- ClinicalTrials.gov ID
- NCT04348877
- Acronym / sponsor ID
- PRA-001 / FMASU P15/ 2020
- Conditions
- Coronavirus Disease (COVID-19)
- Keywords
- Egypt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Apr 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.
Prospective interventional study, single arm of purified convalescent plasma transfusion as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (75mg/12 hours for 5-10 days) and hydroxychroquine (400mg twice in first day, 200 twice for 4-9 days) ± Azithromycin 500mg daily for 5 days
Detailed description
- Selection of donor according to the eligibility criteria
- Full medical history, concurrent medications, demographic data will be obtained.
- Complete clinical assessment with special emphasis on assessment of resolution of symptoms
- Body weight, height.
- A confirmatory diagnostic test result (e.g., nasopharyngeal swab) at the time of illness or serological test for SARS-CoV-2 antibodies after recovery will be collected
- COVID -19 PCR test by nasopharyngeal swab.
- Complete blood count with differential counts
- Viral screening (HBV, HCV, HIV \& Syphilis): Conventional testing by chemiluminescence followed by nucleic acid testing (NAT)
- Donor's written consent
- Plasma collection:
- Donor to be connected to microprocessor controlled plasmapheresis machine containing single use disposable kit for every donor.
- A certain amount of blood is withdrawn by pump from the patient and immediately anticoagulated then centrifuged in the machine.
- Blood components are separated into different layers according to the density of each component.
- The plasma layer is collected and diverted into the collection bag while all other components are infused back to the patient, thus ending the first cycle.
- Cycles are repeated until collecting a total of 400 ml of filtered plasma in the collection bag; that is one complete therapeutic dose for one patient in need.
- Pathogen reduction/Viral inactivation by the Solvent/Detergent (S/D) method:
- SD method is the gold standard for inactivation of enveloped viruses HBV, HCV and HIV. All these viruses have a lipid outer coat enveloping the nucleic acid.
- Tri-N Butyl Phosphate (TNBP) acts as an organic solvent to remove lipids from the membranes of pathogens.Tween-20 is a non-ionic detergent that stabilizes TNBP and disrupts lipid bilayers, thus easing the extraction of lipids. Since the solvent is toxic, it is removed using a sterile vegetable oil (Castor oil).
- Measuring remnants of TNBP:
- By chromatography in Ain Shams Toxicology Center.
- Concentration should be less than 10 ppm.
- Screening phase for patients selection:
- Obtaining informed consent: Written signed and dated informed consent will be obtained from each patient before being entered into the study. The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial. This will be obtained from each subject in accordance with the recommendation of the revised Declaration of Helsinki. The investigator will explain the nature, purpose and risks of the study. It will be clearly stated that the patient is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal. In case the patient is unable to provide his/her consent the legal guardian will give verbal approval on behaves of the patient and after he he/she will be well informed by the study design, procedure, risk and benefits over phone call. If it is difficult to reach the legal guardian, emergency approval will be obtained by Professional Legal Representative who will be the head authorities of the isolation hospital.
- Full medical history, concurrent medications, demographic data will be obtained.
- A thorough physical examination will be performed.
- Body weight, height, BMI, vital signs (blood pressure, heart rate and temperature) and Blood oxygen saturation) will be recorded.
- Chest x-ray and CT scan for chest will be recorded
- Ventilation parameters to be recorded if ventilated
- Laboratory to perform the following tests: Complete blood count with differential counts, Renal function tests (RFTs) (serum creatinine), Liver function tests (LFTs) (alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin), Coagulation test; prothrombin time and INR and D.dimer, HIV Ab, HCV Ab and HBV surface antigen (HBsAg), COVID -19 PCR test by nasopharyngeal swab. Urine pregnancy test for females.
- Treatment phase for eligible patients:
- Eligibility confirmed
- Treatment with collected plasma in a dose of 400 ml on single therapeutic dose on Day1 as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (150mg/12 hours for 5-10 days) and hydroxychroquine (400mg twice in first day, 200 twice for 4-9 days) ± Azithromycin 500mg daily for 5 days.
- The patient's health status, and the presence of adverse events will be assessed daily
- Complete physical examination will be performed daily.
- Vital signs (blood pressure, heart rate and temperature) will be recorded.
- Follow-up CXR will be performed on daily and /CT scan will be performed as clinically indicated
- Coagulation test; prothrombin time and INR and D.dimer will be re-reassessed on day 3, 7, and 14
- HIV Ab, HCV Ab and HBV surface antigen (HBsAg) will be repeated at day 14
- COVID -19 PCR test by nasopharyngeal swab will be repeated every 72 hours.
- Post treatment period up to 30 days after end of treatment:
- Vital signs (blood pressure, heart rate and temperature) will be recorded.
- Symptoms and signs assessment will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Antibody-Rich Plasma from COVID-19 recovered patients
| Arm | Type | Receives |
|---|---|---|
| Antibody-Rich Plasma | Other | Other: Antibody-Rich Plasma from COVID-19 recovered patients400 millimeter of Antibody-Rich Plasma from COVID-19 recovered patients will be transfused to patients with severe or immediately life-threatening COVID-19 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult 18 -80 years old
- Must have laboratory confirmed COVID-19
- Must have severe or immediately life-threatening COVID-19, 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 Life-threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure
- Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative
Key exclusion criteria (2 listed)
- Patient with mild or moderate COVID-19
- Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.
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 |
|---|---|---|
| Antibody-Rich Plasma from COVID-19 recovered patients400 millimeter of Antibody-Rich Plasma from COVID-19 recovered patients will be transfused to patients with severe or immediately life-threatening COVID-19 | Other | Antibody-Rich Plasma |
Primary outcome
viral COVID-19 clearance
Time frame: 14 days
Two successive negative COVID-19 PCR analysis tests 72 hours apart
2 secondary outcomes
Decrease of radiological abnormalities
Time frame: 14 days
Clinical improvement
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibody-Rich Plasma from COVID-19 recovered patients in people with Coronavirus Disease (COVID-19), run by Ain Shams 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 4 inclusion and 2 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 20 Apr 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
viral COVID-19 clearance (time frame: 14 days). 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 20 Apr 2020.