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Covid19Early Phase 1NCT04530370

Efficacy and Safety of Recovered Covid 19 Plasma Transfusion to Covid 19 Severly Ill Patients

A Early Phase 1 study testing recovered covid 19 patients plasma in people with Covid19, run by South Valley University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The discovery of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the outbreak of coronavirus disease 2019 (COVID-19) are causing public health emergencies. A handful pieces of literature have summarized its clinical and radiologic features, whereas therapies for COVID-19 are rather limited. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
recovered covid 19 patients plasma
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteEgypt
Study dates
29 May 2020to 1 Sep 2020
Phase
Early Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients ≥ 18 years, with confirmed laboratory covid-19, and have one or more of the following 4 conditions:
  • 1. respiratory frequency ≥ 30/min,
  • 2. blood oxygen saturation ≤ 93% on room air,
  • 3. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 mmHg,
  • 4. pulmonary infiltrates occupying more than 50% of both lungs.

Who cannot join

  • Any patient with prior allergic history to plasma or
  • allergy to plasma products or
  • septic shock or
  • multiple organ failure.

Trial locations and contacts

1 site in 1 country.

ossama h salman, MD,PhD contact

+201223001113

ossamas@hotmail.com

Egypt1 site, 1 recruiting
  • South Valley University

    Qina, 83523

    Gad S Gad, MD, +201099075675, Kmashson@hotmail.com

    Recruiting

Other trials in Egypt

About this study

The discovery of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the outbreak of coronavirus disease 2019 (COVID-19) are causing public health emergencies. A handful pieces of literature have summarized its clinical and radiologic features, whereas therapies for COVID-19 are rather limited. To evaluate the efficacy of convalescent plasma therapy in COVID-19 patients.

Read the detailed description

Coronavirus disease 2019 (COVID-19) is a highly contagious pulmonary disease caused by a newly discovered strains of coronavirus family. The clinical pictures could range from a symptomatic to severe and can lead to hospitalization, breathing difficulties and death. Unfortunately, no vaccine or specific treatment is available so far. 1 There have been encouraging clinical researches using immunotherapy as a recent treatment modality against Covid 19 viral infections. Of particular interest, is passive immunotherapy which is the passive transfer of readymade antibodies (humoral immunity) from recovered individuals to patients in active illness. 2 Plasma of recovered patients, a classic cell transfer therapy, has been used successfully to prevent and treat many infectious diseases in the past including: H1N1 pandemic influenza A, avian influenza A (H5N1), SARS-CoV and, Ebola virus disease, MERS-CoV respiratory syncytial virus, Zika viruses, human cytomegalovirus and rabies. Unfortunately, recovered plasma did not show successful results in combating Ebola outbreak3 Neutralizing antibody from recovered SARS patients could interfere with SARS-CoV-2 from penetrating through host cells in vitro. 4 Moreover, neutralizing antibodies (NAbs) from recovered SARS-CoV patients were highly correlated, peaking at month 4 after the onset of disease, could be titrated in plasma of 90% of patients for as long as 2 years, decreasing gradually thereafter.5

SARS-CoV-2 is a member of β-coronavirus family. It is a single-stranded RNA genome consists of 30 kb nucleotides, which transcript 4 main structural proteins: spike (S), membrane (M), envelope (E), and nucleocapsid (N) proteins. The virus characteristic appearance stems from, the S protein which is club shape glycoprotein radiating in a crown like configuration. 6 Genome researches have shown that interlocking between the receptor-binding domain of S protein and the angiotensin-converting enzyme 2 (ACE2) facilitates SARS-CoV-2 entry into the host cells. 7 The similarity of the receptor-binding sites between SARS-CoV-2 and SARS-CoV explains their shared pathogenicity and biological traits. Moreover, both covid-19 and SARS share common clinical (fever, cough, body aches, and dyspnea) and typical radiological manifestations (multifocal ground-glass opacities (GGOs) and subsegmental areas of consolidation). 8 Nevertheless, both viruses are highly contagious with incubation period range from several days to two weeks.

Patients with SARS-CoV-2 infection produce different antibodies against different viral antigenic proteins (epitomes), and some of these antibodies mediate their action by virus neutralization or by phagocytosis and antibody gated cell toxicity.9 There have been published studies claiming successful patient outcome after transfusion of recovered plasma. One study showed improved clinical pictures, higher discharge rate. 10 Another study demonstrated that viral RNA disappeared in patient serums a week post transfusion. 11 Another study compared the clinical improvement of recovered plasma transfusion with steroids in SARS patients with critical condition. They observed that recovered plasma patients had a high hospital discharge rate, better clinical outcome than the steroid group, with no transfusion related unwanted effects.12 A large meta-analysis of 1703 influenza pneumonia patients who had been transfused recovered plasma, showed a marked decrease of viral load and 21% decrease in mortality. 13 There are fast growing numbers of new COVID-19 cases every day, and disease-related morbidity and mortality is increasing. The purpose of our study was to test the efficacy and safety of transfusing plasma from patients who have recovered from COVID-19, to patients with COVID-19 in severe condition.

Conditions
Covid19
Being tested
recovered covid 19 patients 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.

  • recovered covid 19 patients plasmaBiological

    we transfused 150 ml of recovered covid 19 plasma to severely ill patients with confirmed covid 19 disease

Study groups in NCT04530370
Study groupRoleWhat they receive
Recovered covid 19 plasmaExperimentalNot described
Receives: Biological: recovered covid 19 patients plasma
controlledPlacebo comparatorNot described
Receives: Biological: recovered covid 19 patients plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Satisfactory outcome

    Patients' response to recovered Covid 19 plasma (RCP) during 5 days after transfusion, was our primary goal. It was categorized into either satisfactory or unsatisfactory outcomes. We defined satisfactory outcome as two or more of the following 4 conditions/ or otherwise unsatisfactory: 1. respiratory frequency < 30/min, 2. Sustain blood oxygen saturation ≥93% on room air, 3. partial pressure of arterial oxygen to fraction of inspired oxygen ratio > 300 mmHg, 4. Regression of pulmonary infiltrates occupying less than 50% of both lungs.

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start29 May 2020
  3. Primary completionSep 2020 (estimated)
  4. Study completion1 Sep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04530370
Sponsor's protocol ID
ossamahamdyresearcher7
Status last verified
Aug 2020
First submitted
26 Aug 2020
Last updated
28 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

    PubMed 37162745
  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

    PubMed 36734509
  • Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.

    PubMed 34013969

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing recovered covid 19 patients plasma in people with Covid19, run by South Valley 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 5 inclusion and 4 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 28 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 ossama h salman, MD,PhD (+201223001113, ossamas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Satisfactory outcome (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04530370, which also lists 3 linked publications.

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 28 Aug 2020.

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