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Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) plus Aerosolized 13 cis retinoic acidWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Correlated MeSH Terms (1)


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D055370 Lung Injury NIH 0.21

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There is one clinical trial.

Clinical Trials


1 Combination of Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP and Isotretinoin Could be Promising COVID-19 Infection- and Lung Injury Preventing Drug Better Than Recombinant Human ACE2

Combination of Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP and Isotretinoin Could be Promising COVID-19 Infection- and Lung Injury Preventing Drug Better Than Recombinant Human ACE2 Mahmoud ELkazzaz1 1Department of chemistry and biochemistry, Faculty of Science, Damietta University, GOEIC, Egypt. _____________________________________________________________________________________________ ________________________________________________________________________ B38-CAP is a bacteria-derived ACE2-like enzyme that suppresses hypertension and cardiac dysfunction Angiotensin-converting enzyme 2 (ACE2) is critically involved in cardiovascular physiology and pathology, and is currently clinically evaluated to treat acute lung failure. Here we show that the B38-CAP, a carboxypeptidase derived from Paenibacillus sp. B38, is an ACE2-like enzyme to decrease angiotensin II levels in mice. In protein 3D structure analysis, B38-CAP homolog shares structural similarity to mammalian ACE2 with low sequence identity. A study demonstrated that the bacterial B38-CAP as an ACE2-like carboxypeptidase, indicating that evolution has shaped a bacterial carboxypeptidase to a human ACE2-like enzyme. Bacterial engineering could be utilized to design improved protein drugs for hypertension and heart failure. pretreatment of B38-CAP markedly down regulated a massive increase of plasma Ang II levels at 5 min after Ang II injection In addition to the currently used drugs to inhibit Ang II generation or signaling, such as ACE inhibitors or Angiotensin receptor blockers, direct down-modulation of Ang II levels by rhACE2 protein is one of the promising candidates for new therapeutic strategy in cardiovascular disease and other Ang II-related diseases, e.g. ARDS. On the other hand, although mass production of rhACE2 as a protein drug costs due to requirement of mammalian cell expression systems, B38-CAP is easily prepared with E. coli expression system and is cost effective. Therapeutic efficacy and less toxicity in mouse heart failure models would warrant further investigation of B38-CAP or other microbial carboxypeptidases in disease models. Finally the principal investigator expects that treatment with ACE2-like enzyme of bacteria B38-CAP expected to work efficiently Like human ACE2 and it will save the lung cells from COVID - 19 inhibitory effect and down regulation of ACE2 because COVID-19 binds to human ACE2 and down regulates it and this receptors is very important for lung cells survival and function So ,the principal investigator also expects that B38-CAP ACE2 like enzyme may be not recognized by COVID -19 spike protein because evolutionary it is too far away from human ace2 and human ACE2 is a real receptor of COVID -19 not ACE2 like enzyme but in the same time it will make the same function of human ACE2 In another study by Sinha et al who analyzed a publicly available Connectivity Map (CMAP) dataset of pre/post transcriptomic profiles for drug treatment in cell lines for over 20,000 small molecules, isotretinoin was the strongest down-regulator of ACE 2 receptors. On the other hand, they found 6 drugs in CMAP that are currently being investigated in clinical trials for treating COVID-19 (chloroquine, thalidomide, methylprednisolone, losartan, lopinavir and ritonavir, from clinicaltrials.gov), none of which was found to significantly alter ACE2 expression (P>0.1) Moreover, another study demonstrated that isotretinoin is a Potential papain like protease (PLpro) inhibitors which is a protein encoded by SARS-CoV-2 genes and considered one of the proteins that should be targeted in COVID-19 treatment by performing target-based virtual ligand screening . So, the principal investigator expects strong inhibition of COVID - 19 infection And rescuing the lung cells from its serious attack by treating with ACE2 like enzyme and Isotretinoin Keywords: COVID 2019 , Isotretinoin,B38-CAP , Bacterial ACE2 receptors -like enzyme , rhACE226.

NCT04382950 COVID Combination Product: Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) plus Aerosolized 13 cis retinoic acid
MeSH:Lung Injury

Primary Outcomes

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

Measure: Time course of body temperature (fever)

Time: at 14 days

Secondary Outcomes

Description: Compare viral load between two groups over time.

Measure: Viral load over time

Time: 14 days

Description: PaO2/FiO2 ratio

Measure: P/F ratio over time

Time: 14 days

Description: 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.

Measure: Sequential organ failure assessment score(SOFA score) over time

Time: 14 days

Measure: Pulmonary Severity Index (PSI)

Time: 14 days

Description: 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.

Measure: Image examination of chest over time

Time: 14 days

Measure: Proportion of subjects who progressed to critical illness or death

Time: at 14 days

Measure: Time from first dose to conversion to normal or mild pneumonia

Time: 14 days

Measure: T-lymphocyte counts over time

Time: 14 days

Measure: C-reactive protein levels over time

Time: 14 days

Measure: Angiotensin II (Ang II) changes over time

Time: 14 days

Measure: Angiotensin 1-7 (Ang 1-7) changes over time

Time: 14 days

Measure: Angiotensin 1-5 (Ang 1-5) changes over time

Time: 14 days

Measure: Renin changes over time

Time: 14 days

Measure: Aldosterone changes over time

Time: 14 days

Measure: Angiotensin-converting enzyme (ACE) changes over time

Time: 14 days

Measure: Interleukin 6 (IL-6) changes over time

Time: 14 days

Measure: Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time

Time: 14 days

Measure: Plasminogen activator inhibitor type-1 (PAI-1) changes over time

Time: 14 days

Measure: Von willebrand factor (vWF) changes over time

Time: 14 days

Measure: Tumor necrosis factor-α (TNF-α) changes over time

Time: 14 days

Measure: Soluble receptor for advanced glycation end products (sRAGE) changes over time

Time: 14 days

Measure: Surfactant protein-D (SP-D) changes over time

Time: 14 days

Measure: Frequency of adverse events and severe adverse events

Time: 14 days


No related HPO nodes (Using clinical trials)