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

NCT04375046 | Unknown Phase 1 DMC

• 1 other identifier: proposed by Mahmoud kazazzaz
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Department of chemistry and biochemistry, Faculty of Science, Damietta University, Egypt.
2. 2.Department of Internal Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt
3. 3.Hepatology,Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital, Egypt
4. 4.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.

Conditions

COVID-19

Keywords

COVID 2019 ,Infection, B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226

Outcome Measures

Primary Outcomes (2)

• Time course of body temperature (fever)

  Compare the time course of body temperature (fever) between two groups over time.

  14 days

• Viral load over time

  Compare viral load between two groups over time.

  14 days

Secondary Outcomes (25)

• P/F ratio over time

  14 days

• Sequential organ failure assessment score(SOFA score) over time

  14 days

• Pulmonary Severity Index (PSI)

  14 days

• Image examination of chest over time

  14 days

• Proportion of subjects who progressed to critical illness or death

  14 days

Study Arms (2)

Experimental: rbACE2 group

EXPERIMENTAL

0.4 mg/kg IV BID for 7 days (unblinded) + standard of care

Drug: Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2)

No Intervention: Control group

NO INTERVENTION

Standard of care; no placebo

Interventions

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

Experimental: rbACE2 group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 -

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead
• The First Hospital of Jilin University: collaborator

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• M.Sc. Mahmoud Elkazzaz, M.Sc.Biochemistry

  General Organization of Export and Import control system

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M.Sc.Mahmoud Elkazzaz, M.Sc.Biochemistry

CONTACT

00201090302015; mahmoudramadan2051@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: July 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share