COVID-19Phase 1Bacterial ACE2NCT04375046
Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP Could be Promising Treatment for COVID-19 Infection- and Its Inflammatory Complications Better Than Recombinant Human ACE2
A Phase 1 study testing Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) in people with COVID-19, run by Kafrelsheikh University.
Trial summary
Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising treatment for COVID-19 infection- and Its inflammatory complications better than recombinant human ACE2 Mahmoud ELkazzaz(1),Tamer Haydara(2),Yousry Abo-amer(3), Quan Liu(4) 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Oct 2021
- Phase
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laboratory diagnosis:
- Respiratory specimen is positive for SARS-CoV-2 nucleic acid by RT-PCR; OR, The viral gene sequencing of the respiratory specimen is highly homologous to known novel coronavirus.
- Fever:
- Axillary temperature >37.3℃
- Respiratory variables (meets one of the following criteria):
- Respiratory rate: RR ≥25 breaths/min
Show all 12Show fewer
- Oxygen saturation ≤93% at rest on room air
- PaO2/FiO2 ≤300 mmHg（1 mmHg=0.133 KPa）
- Pulmonary imaging showed that the lesions progressed more than 50% within 24-48 hours, and the patients were managed as severe
- HBsAg negative, or HBV DNA ≤10^4 copy/ml if HBsAg positive; anti-HCV negative; HIV negative two weeks prior to signed Informed Consent Form (ICF)
- Appropriate ethics approval and
- ICF -
Who cannot join
- Age <18 years; Age >80 years
- Pregnant or breast feeding woman or with positive pregnancy test result P/F <100 mmHg
- Moribund condition (death likely in days) or not expected to survive for >7 days Refusal by attending MD
- Not hemodynamically stable in the preceding 4 hours (MAP ≤65 mmHg, or SAP <90 mmHg, DAP <60 mmHg, vasoactive agents are required)
- Patient on invasive mechanical ventilation or ECMO
- Patient in other therapeutic clinical trial within 30 days before ICF
Show all 13Show fewer
- Receive any other ACE inhibitors (ACEI), angiotensin-receptor blockers (ARB) treatment within 7 days before ICF
- Chronic immunosuppression: current autoimmune diseases or patients who received immunotherapy within 30 days before ICF
- Hematologic malignancy (lymphoma, leukemia, multiple myeloma)
- Other patient characteristics (not thought to be related to underlying COVID-19) that portend a very poor prognosis (e.g, severe liver failure, and ect)
- Known allergy to study drug or its ingredients related to renin-angiotensin system (RAS), or frequent and/or severe allergic reactions with multiple medications
- Other uncontrolled diseases, as judged by investigators
- Body weight ≥85 kg
Trial locations and contacts
No sites are listed yet.
About this study
Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising treatment for COVID-19 infection- and Its inflammatory complications better than recombinant human ACE2
Mahmoud ELkazzaz(1),Tamer Haydara(2),Yousry Abo-amer(3), Quan Liu(4)
Read more
- Department of chemistry and biochemistry, Faculty of Science, Damietta University, Egypt.
- Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt
- Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital, Egypt
- School of Life Sciences and Engineering, Foshan University, Foshan, Guangdong Province; Laboratory of Emerging Infectious Disease, Institute of Translational Medicine, The First Hospital of Jilin University, Changchun, China.
Abstract
The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected over 100 million people causing over 2.4 million deaths over the world, and it is still expanding. There is an urgent need for targeted and effective COVID-19 treatments which has put great pressure on researchers across the world for developing effective drugs. This paper reviews the possibility of using Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP to treat SARS-CoV-2 based on the intracellular mechanism of SARS-CoV-2 transmission and consequences caused. Angiotensin-converting enzyme 2 (ACE2) plays a key role in cardiovascular physiology and pathology, and it's being currently being investigated as a potential covid-19 and acute lung failure treatment through several clinical trials.. The SARS-CoV2 binding site was identified as ACE2, a part of the RAAS, which is known to protect the lung from injuries. it has been postulated that SARS-CoV-2 binding to ACE2 may attenuate residual ACE2 activity, skewing the ACE/ACE2 balance to a state of heightened angiotensin II activity leading to inflammatory and oxidative organ damage, as well as pulmonary vasoconstriction, which can lead to acute lung injury.. Therefore, treatment with recombinant soluble ACE2 protein and drugs that up regulate ACE2 may alleviate pulmonary complication. In animal models including heart failure, acute lung injury, and diabetic nephropathy, recombinant human ACE2 protein (rhACE2), which is devoid of its membrane-anchored domain thus soluble, has been shown to have beneficial effects. Despite its positive effects, rhACE2 is a glycosylated protein, which necessitates a time- and cost-intensive protein expression system using mammalian or insect cells, which may be inconvenient in drug production and medical economics. Moreover, we hypothesis that treating COVID-19 patients with recombinant soluble ACE2 protein may induce autoantibodies and T cells to cellular ACE2.Furthermore, rhACE2 may interact with spike protein based vaccine and worsen its effect . These autoantibodies may generated by enforced presentation of the soluble Angiotensin-converting enzyme 2 (ACE2) protein in a complex with COVID-19 Spike protein in fragment crystallizable (FC) Receptor positive Antigen Presenting Cells in the blood The development of autoantibodies might make injury and damage to the host epithelial cells and hamper their ACE2 dependent function in lungs, intestine and testes which express ACE2. In addition to inducing platelet aggregation and thrombosis . Although it has been stated that immune response associated with the chronic infusion of rhACE2 resulting in the degradation of rhACE226, this was not the case with B38-CAP; no antibodies against B38-CAP were detected in the serum of mice infused with B38-CAP for two weeks... In this case we suggest that bacterial engineering could be used to develop better protein drugs for COVID-19 treatment... B38-CAP is an ACE2-like enzyme derived from bacteria that reduces hypertension and cardiac dysfunction. Angiotensin-converting enzyme 2 (ACE2) plays a key role in cardiovascular physiology and pathology, and it is currently being studied in clinical trials to treat acute lung failure. In mice, B38-CAP treatment prevented angiotensin II-induced hypertension, cardiac hypertrophy, and fibrosis. B38-CAP is an ACE2-like enzyme derived from bacteria, demonstrating that evolution has shaped a bacterial carboxypeptidase (B38-CAP) to a human ACE2-like enzyme. As a result, we think that treating COVID-19-infected patients with Bacterial ACE2 like enzymes, rather than human ACE2, may be preferable because it will perform the same role as human ACE2 and may not be recognized by COVID-19 spike protein
Keywords: COVID 2019 ,Infection, B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226.
Read the detailed description
Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising treatment for COVID-19 infection- and Its inflammatory complications better than recombinant human ACE2
This is a small pilot study investigating whether there is any efficacy signal that warrants a larger Phase 2B trial, or any harm that suggests that such a trial should not be done. It is not expected to produce statistically significant results in the major endpoints. The investigator will examine all of the biologic, physiological, and clinical data to determine whether a Phase 2B trial is warranted.
Primary efficacy analysis will be carried only on patients receiving at least 4 doses of active drug. Safety analysis will be carried out on all patients receiving at least one dose of active drug.
It is planned to enroll more than or equal to 24 subjects with COVID-19. It is expected to have at least 12 evaluable patients in each group.
Experimental group: 0.4 mg/kg rbACE2 IV BID and standard of care Control group: standard of care Intervention duration: up to 7 days of therapy No planned interim analysis.
- Conditions
- COVID-19
- Being tested
- Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2)
- Keywords
- COVID 2019 ,Infection, B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2)Drug
In this study, the experimental group will receive 0.4 mg/kg rbACE2 IV
| Study group | Role | What they receive |
|---|---|---|
| Experimental: rbACE2 group | Experimental | 0.4 mg/kg IV BID for 7 days (unblinded) + standard of care Receives: Drug: Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) |
| No Intervention: Control group | No intervention | Standard of care; no placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time course of body temperature (fever)
Compare the time course of body temperature (fever) between two groups over time.
Measured: 14 days
Viral load over time
Compare viral load between two groups over time.
Measured: 14 days
Secondary outcomes (25)
P/F ratio over time
PaO2/FiO2 ratio
Measured: 14 days
Sequential organ failure assessment score(SOFA score) over time
SOFA, including assessment of respiratory, blood, liver, circulatory, nerve, kidney, from 0 to 4 scores in each systems, the higher scores mean a worse outcome.
Measured: 14 days
Pulmonary Severity Index (PSI)
Measured: 14 days
Image examination of chest over time
Based on radiologist's assessment of inflammatory exudative disease, category as follows: significant improvement, partial improvement, no improvement, increase of partial exudation, significant increase in exudation, unable to judge.
Measured: 14 days
Proportion of subjects who progressed to critical illness or death
Measured: 14 days
Time from first dose to conversion to normal or mild pneumonia
Measured: 14 days
T-lymphocyte counts over time
Measured: 14 days
C-reactive protein levels over time
Measured: 14 days
Angiotensin II (Ang II) changes over time
Measured: 14 days
Angiotensin 1-7 (Ang 1-7) changes over time
Measured: 14 days
Angiotensin 1-5 (Ang 1-5) changes over time
Measured: 14 days
Renin changes over time
Measured: 14 days
Aldosterone changes over time
Measured: 14 days
Angiotensin-converting enzyme (ACE) changes over time
Measured: 14 days
Angiotensin-converting enzyme 2 (ACE2) changes over time
Measured: 14 days
Interleukin 6 (IL-6) changes over time
Measured: 14 days
Interleukin 8 (IL-8) changes over time
Measured: 14 days
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time
Measured: 14 days
Plasminogen activator inhibitor type-1 (PAI-1) changes over time
Measured: 14 days
Von willebrand factor (vWF) changes over time
Measured: 14 days
Tumor necrosis factor-α (TNF-α) changes over time
Measured: 14 days
Soluble receptor for advanced glycation end products (sRAGE) changes over time
Measured: 14 days
Surfactant protein-D (SP-D) changes over time
Measured: 14 days
Angiopoietin-2 changes over time
Measured: 14 days
Frequency of adverse events and severe adverse events
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 posted5 May 2020
- Study startJul 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University
- Responsible party
- Principal investigator, Mahmoud Ramadan mohamed Elkazzaz, Kafrelsheikh University
- Investigators
- M.Sc. Mahmoud Elkazzaz, M.Sc.Biochemistry, Principal investigator, General Organization of Export and Import control system
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375046
- Sponsor's protocol ID
- proposed by Mahmoud kazazzaz
- Acronym
- Bacterial ACE2
- Status last verified
- Jun 2021
- First submitted
- 1 May 2020
- Last updated
- 9 Jun 2021
- 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 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP Could be Promising Treatment for COVID-19 Infection- and Its Inflammatory Complications Better Than Recombinant Human ACE2
- ClinicalTrials.gov ID
- NCT04375046
- Acronym / sponsor ID
- Bacterial ACE2 / proposed by Mahmoud kazazzaz
- Conditions
- COVID-19
- Keywords
- COVID 2019 ,Infection, B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University
- Study start
- Jul 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 5 May 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.
Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising treatment for COVID-19 infection- and Its inflammatory complications better than recombinant human ACE2
Mahmoud ELkazzaz(1),Tamer Haydara(2),Yousry Abo-amer(3), Quan Liu(4)
- Department of chemistry and biochemistry, Faculty of Science, Damietta University, Egypt.
- Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt
- Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital, Egypt
- School of Life Sciences and Engineering, Foshan University, Foshan, Guangdong Province; Laboratory of Emerging Infectious Disease, Institute of Translational Medicine, The First Hospital of Jilin University, Changchun, China.
Abstract
The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected over 100 million people causing over 2.4 million deaths over the world, and it is still expanding. There is an urgent need for targeted and effective COVID-19 treatments which has put great pressure on researchers across the world for developing effective drugs. This paper reviews the possibility of using Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP to treat SARS-CoV-2 based on the intracellular mechanism of SARS-CoV-2 transmission and consequences caused. Angiotensin-converting enzyme 2 (ACE2) plays a key role in cardiovascular physiology and pathology, and it's being currently being investigated as a potential covid-19 and acute lung failure treatment through several clinical trials.. The SARS-CoV2 binding site was identified as ACE2, a part of the RAAS, which is known to protect the lung from injuries. it has been postulated that SARS-CoV-2 binding to ACE2 may attenuate residual ACE2 activity, skewing the ACE/ACE2 balance to a state of heightened angiotensin II activity leading to inflammatory and oxidative organ damage, as well as pulmonary vasoconstriction, which can lead to acute lung injury.. Therefore, treatment with recombinant soluble ACE2 protein and drugs that up regulate ACE2 may alleviate pulmonary complication. In animal models including heart failure, acute lung injury, and diabetic nephropathy, recombinant human ACE2 protein (rhACE2), which is devoid of its membrane-anchored domain thus soluble, has been shown to have beneficial effects. Despite its positive effects, rhACE2 is a glycosylated protein, which necessitates a time- and cost-intensive protein expression system using mammalian or insect cells, which may be inconvenient in drug production and medical economics. Moreover, we hypothesis that treating COVID-19 patients with recombinant soluble ACE2 protein may induce autoantibodies and T cells to cellular ACE2.Furthermore, rhACE2 may interact with spike protein based vaccine and worsen its effect . These autoantibodies may generated by enforced presentation of the soluble Angiotensin-converting enzyme 2 (ACE2) protein in a complex with COVID-19 Spike protein in fragment crystallizable (FC) Receptor positive Antigen Presenting Cells in the blood The development of autoantibodies might make injury and damage to the host epithelial cells and hamper their ACE2 dependent function in lungs, intestine and testes which express ACE2. In addition to inducing platelet aggregation and thrombosis . Although it has been stated that immune response associated with the chronic infusion of rhACE2 resulting in the degradation of rhACE226, this was not the case with B38-CAP; no antibodies against B38-CAP were detected in the serum of mice infused with B38-CAP for two weeks... In this case we suggest that bacterial engineering could be used to develop better protein drugs for COVID-19 treatment... B38-CAP is an ACE2-like enzyme derived from bacteria that reduces hypertension and cardiac dysfunction. Angiotensin-converting enzyme 2 (ACE2) plays a key role in cardiovascular physiology and pathology, and it is currently being studied in clinical trials to treat acute lung failure. In mice, B38-CAP treatment prevented angiotensin II-induced hypertension, cardiac hypertrophy, and fibrosis. B38-CAP is an ACE2-like enzyme derived from bacteria, demonstrating that evolution has shaped a bacterial carboxypeptidase (B38-CAP) to a human ACE2-like enzyme. As a result, we think that treating COVID-19-infected patients with Bacterial ACE2 like enzymes, rather than human ACE2, may be preferable because it will perform the same role as human ACE2 and may not be recognized by COVID-19 spike protein
Keywords: COVID 2019 ,Infection, B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226.
Detailed description
Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP could be promising treatment for COVID-19 infection- and Its inflammatory complications better than recombinant human ACE2
This is a small pilot study investigating whether there is any efficacy signal that warrants a larger Phase 2B trial, or any harm that suggests that such a trial should not be done. It is not expected to produce statistically significant results in the major endpoints. The investigator will examine all of the biologic, physiological, and clinical data to determine whether a Phase 2B trial is warranted.
Primary efficacy analysis will be carried only on patients receiving at least 4 doses of active drug. Safety analysis will be carried out on all patients receiving at least one dose of active drug.
It is planned to enroll more than or equal to 24 subjects with COVID-19. It is expected to have at least 12 evaluable patients in each group.
Experimental group: 0.4 mg/kg rbACE2 IV BID and standard of care Control group: standard of care Intervention duration: up to 7 days of therapy No planned interim analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: rbACE2 group | Experimental | Drug: Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2)0.4 mg/kg IV BID for 7 days (unblinded) + standard of care |
| No Intervention: Control group | No intervention | –Standard of care; no placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Laboratory diagnosis:
- Respiratory specimen is positive for SARS-CoV-2 nucleic acid by RT-PCR; OR, The viral gene sequencing of the respiratory specimen is highly homologous to known novel coronavirus.
- Fever:
- Axillary temperature >37.3℃
- Respiratory variables (meets one of the following criteria):
Key exclusion criteria (13 listed)
- Age <18 years; Age >80 years
- Pregnant or breast feeding woman or with positive pregnancy test result P/F <100 mmHg
- Moribund condition (death likely in days) or not expected to survive for >7 days Refusal by attending MD
- Not hemodynamically stable in the preceding 4 hours (MAP ≤65 mmHg, or SAP <90 mmHg, DAP <60 mmHg, vasoactive agents are required)
- Patient on invasive mechanical ventilation or ECMO
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 |
|---|---|---|
| Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2)In this study, the experimental group will receive 0.4 mg/kg rbACE2 IV | Drug | Experimental: rbACE2 group |
Primary outcome
Time course of body temperature (fever)
Time frame: 14 days
Compare the time course of body temperature (fever) between two groups over time.
Viral load over time
Time frame: 14 days
Compare viral load between two groups over time.
25 secondary outcomes
P/F ratio over time
Time frame: 14 days
Sequential organ failure assessment score(SOFA score) over time
Time frame: 14 days
Pulmonary Severity Index (PSI)
Time frame: 14 days
Image examination of chest over time
Time frame: 14 days
Proportion of subjects who progressed to critical illness or death
Time frame: 14 days
Time from first dose to conversion to normal or mild pneumonia
Time frame: 14 days
T-lymphocyte counts over time
Time frame: 14 days
C-reactive protein levels over time
Time frame: 14 days
Angiotensin II (Ang II) changes over time
Time frame: 14 days
Angiotensin 1-7 (Ang 1-7) changes over time
Time frame: 14 days
Angiotensin 1-5 (Ang 1-5) changes over time
Time frame: 14 days
Renin changes over time
Time frame: 14 days
Aldosterone changes over time
Time frame: 14 days
Angiotensin-converting enzyme (ACE) changes over time
Time frame: 14 days
Angiotensin-converting enzyme 2 (ACE2) changes over time
Time frame: 14 days
Interleukin 6 (IL-6) changes over time
Time frame: 14 days
Interleukin 8 (IL-8) changes over time
Time frame: 14 days
Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time
Time frame: 14 days
Plasminogen activator inhibitor type-1 (PAI-1) changes over time
Time frame: 14 days
Von willebrand factor (vWF) changes over time
Time frame: 14 days
Tumor necrosis factor-α (TNF-α) changes over time
Time frame: 14 days
Soluble receptor for advanced glycation end products (sRAGE) changes over time
Time frame: 14 days
Surfactant protein-D (SP-D) changes over time
Time frame: 14 days
Angiopoietin-2 changes over time
Time frame: 14 days
Frequency of adverse events and severe adverse events
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 9 Jun 2021.
- 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.
M.Sc. Mahmoud Elkazzaz, M.Sc.Biochemistry principal investigator
General Organization of Export and Import control system
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) in people with COVID-19, run by Kafrelsheikh University.
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 12 inclusion and 13 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 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 M.Sc.Mahmoud Elkazzaz, M.Sc.Biochemistry (00201090302015, mahmoudramadan2051@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time course of body temperature (fever) (time frame: 14 days). The study lists 2 primary outcomes in all. 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 9 Jun 2021.