Severe Acute Respiratory Syndrome-related CoronavirusPhase 4NCT05711810

Medicine-induced Cardiac Hemodialysis on COVID-19

A Phase 4 study testing Nifedipine 30 MG, Kangzhu BPCB0A-3A and Low Mobility in people with Severe Acute Respiratory Syndrome-related Coronavirus and Renal Dialysis, run by Yang I. Pachankis at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The clinical trial studies the human pathogen of SARS-CoV-2, with a specificity in the circulating Spike 2 protein in the human system. The clinical trial hypothesizes that SARS-CoV-2 human pathogen arises from immune attacks, underlying the severe physiological symptoms that can be lethal. Read more about this study

Who is it for?: Any age
Conditions the study is for: Severe Acute Respiratory Syndrome-related Coronavirus, Renal Dialysis, Vaccines
What is being tested?: Nifedipine 30 MG, Kangzhu BPCB0A-3A and Low Mobility
Type of treatment: Vaccines, Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteChina
Study dates: 2 Jan 2023to 12 Jan 2023
Phase: Phase 4
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

No mRNA vaccinated poisoning have been included currently, but scientific evidence suggest the methods of vaccination are irrelevant to the conditions. It is theorized that the more advanced the vaccine production technology, the deeper the poisoning.

Who cannot join

healthy individuals with no myocarditis or unvaccinated without infection by SARS-CoV series
persons with diabetes (Paxlovid and PrEP treatments can be applied according to availability)

Trial locations and contacts

1 site in 1 country.

China1 site

Residential Address
Chongqing, Chongqing Municipality, 402762

Other trials in China

About this study

Official title: Cardiac Transfer of SARS-CoV-2 Spike Protein Circulation Techniques - Medicine Induced Hemodialysis on "Vaccinated" Immune Attacks

Conditions: Severe Acute Respiratory Syndrome-related Coronavirus, Renal Dialysis, Vaccines, Myocarditis Allergic, Infection Viral
Being tested: Nifedipine 30 MG, Kangzhu BPCB0A-3A, Low Mobility, Enalapril Maleate 10Mg Tab, Lansoprazole 30Mg Ec Cap
Keywords: immune infection, neural infection, spike 2 protein, poison, SARS-CoV-2, precarditis
Medical subject headings: Severe Acute Respiratory Syndrome, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nifedipine 30 MGDrug
Also called Nifedipine Control-release Tablets
Due to initial availability of drugs and the intensities of the patient's symptoms, Nifedipine was used for initial intervention in preventing acute myocarditis from happening.
Kangzhu BPCB0A-3ADiagnostic test
Also called Heart Monitor
The diagnostic test has been used to confirm objective parameters to guide the intervention drug dosages and accessing the risks in sudden death and long term adverse effects.
Low MobilityBehavioural
The behavioral intervention aimed at reducing the risks of sudden and strong blood flows in the patient's system.
Enalapril Maleate 10Mg TabDrug
The intervention aims to reduce the vein flows in Diastolic Blood Pressure, and the risks in blood clot formation and internal vein scratch bleeding.
Lansoprazole 30Mg Ec CapDrug
The intervention aims to server the allergy-inducing proteins to induce renal hemodialysis.
Metoprolol SuccinateDrug
Metoprolol Succinate is used to control the cardiac artery flow amounts and stabilize the patient's heart rate.
Coenzyme Q10Dietary supplement
200 mg per day is used for supplement with the cardiac interventions.
d-alpha tocopherol acetateDietary supplement
The 268 mg twice per day dietary healthcare is the patient's usual daily use.
Omega-3Dietary supplement
The 900 mg twice per day dietary healthcare is the patient's usual daily use.
Duloxetine Hydrochloride 20 MG Oral Capsule, Delayed ReleaseDrug
Also called Neurodiverse
Duloxetine hydrochloride is used for the patient's neurodiverse conditions.
Superoxide DismutaseDrug
Superoxide Dismutase is used to substitute the missing of antiviral drugs.

Study groups in NCT05711810
Study group	Role	What they receive
Experiment Participant	Experimental	COVID-19 recombined vaccinated, 3 dose, no intervention. Nifedipine, oral, 30 mg per day for 2 days, active comparative. Angiotensin-converting enzyme inhibitor, oral, gradually increase to 20 mg per day at night. Beta blocker, oral, 23.75 - 95 mg per day in the morning. Proton-pump inhibitor, oral, 30 mg per day. Duloxetine hydrochloride, oral, placebo, 20 mg per day before sleep. Acetaminophen (sham comparator), oral, 250 mg four times per day for 8 days. Cefuroxime (sham comparator), oral, 100 mg twice per day for 6 days. Papaverine, oral, low-dosage in coughing pills for 4 days. Superoxide Dismutase (active comparator), oral, to be introduced. Bafilomycin A1 (active comparator), oral, 100 ug per kilogram per day, unlikely to be introduced for lack of funding. Receives: Drug: Nifedipine 30 MG; Diagnostic Test: Kangzhu BPCB0A-3A; Behavioral: Low Mobility; Drug: Enalapril Maleate 10Mg Tab; Drug: Lansoprazole 30Mg Ec Cap; Drug: Metoprolol Succinate; Dietary Supplement: Coenzyme Q10; Dietary Supplement: d-alpha tocopherol acetate; Dietary Supplement: Omega-3; Drug: Duloxetine Hydrochloride 20 MG Oral Capsule, Delayed Release; Drug: Superoxide Dismutase

What is being measured

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

Heart Rate
The heart rate is monitored daily, and the primary goal is to stabilize the patient's heart rate.
Measured: 1 day
Electrocardiogram
Electrocardiogram reflects the blood pressure management on the patient's health outcome and potential risks.
Measured: 20 days
Platelet Distribution
Platelet distribution is measured to determine the viral induced blood-borne pathogen in the physiological responses of the patient.
Measured: 10 days
Mean Platelet Volume
MPV is measured to determine the risks in blood clot and internal vein scratches in the patient.
Measured: 10 days
Eosinophil Absolute Number
Eosinophil Absolute Number is measured to determine the intensities of infection in the patient.
Measured: 10 days
Basophil Absolute Number
Basophil Absolute Number is measured on the counteraction of the patient's immune system integrities against the rapid acidification of the viral infection.
Measured: 10 days

Secondary outcomes (1)

Cardiac Enzymes
Cardiac enzymes are measured to locate and eliminate the symptoms' causes, identify potential health risks, and to determine if subsidiary treatments are needed.
Measured: 10 days

Timeline

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

2 Jan 202312 Jan 2023

First posted3 Feb 2023
Study start2 Jan 2023
Primary completion10 Jan 2023
Study completion12 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Severe Acute Respiratory Syndrome-related CoronavirusStudies of the same condition, open and under way.
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 4
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: The crossover model intervenes on the precarditis and myocarditis happenings on the patient, and evaluates the cause of the symptoms. Basic medicines are tested against the pathogens with the immune responses of the patient.
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05711810
Sponsor's protocol ID: SARSCoVVaxPoison
Status last verified: Feb 2023
First submitted: 12 Jan 2023
Last updated: 3 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The emergent intervention started with the PI's research into the virology and post-vaccination adverse effects. The plan was improvised and adjusted accordingly. Statistical analysis was mainly physiological with relation to the virological inductions from the patient's symptomatic responses.

Publications

Liu X, Mostafavi H, Ng WH, Freitas JR, King NJC, Zaid A, Taylor A, Mahalingam S. The Delta SARS-CoV-2 Variant of Concern Induces Distinct Pathogenic Patterns of Respiratory Disease in K18-hACE2 Transgenic Mice Compared to the Ancestral Strain from Wuhan. mBio. 2022 Jun 28;13(3):e0068322. doi: 10.1128/mbio.00683-22. Epub 2022 Apr 14.
PubMed 35420469
Wu Zhang X, Leng Yap Y. Structural similarity between HIV-1 gp41 and SARS-CoV S2 proteins suggests an analogous membrane fusion mechanism. Theochem. 2004 May;677(1):73-76. doi: 10.1016/j.theochem.2004.02.018. Epub 2004 Apr 2.
PubMed 32287546
Hu B, Guo H, Zhou P, Shi ZL. Characteristics of SARS-CoV-2 and COVID-19. Nat Rev Microbiol. 2021 Mar;19(3):141-154. doi: 10.1038/s41579-020-00459-7. Epub 2020 Oct 6.
PubMed 33024307
Xavier LL, Neves PFR, Paz LV, Neves LT, Bagatini PB, Timmers LFSM, Rasia-Filho AA, Mestriner RG, Wieck A. Does Angiotensin II Peak in Response to SARS-CoV-2? Front Immunol. 2021 Jan 14;11:577875. doi: 10.3389/fimmu.2020.577875. eCollection 2020.
PubMed 33519802
Ortiz-Guerrero G, Amador-Munoz D, Calderon-Ospina CA, Lopez-Fuentes D, Nava Mesa MO. Proton Pump Inhibitors and Dementia: Physiopathological Mechanisms and Clinical Consequences. Neural Plast. 2018 Mar 21;2018:5257285. doi: 10.1155/2018/5257285. eCollection 2018.
PubMed 29755512
Tabares L, Betz B. Multiple functions of the vesicular proton pump in nerve terminals. Neuron. 2010 Dec 22;68(6):1020-2. doi: 10.1016/j.neuron.2010.12.012.
PubMed 21172605
Goldstein FC, Steenland K, Zhao L, Wharton W, Levey AI, Hajjar I. Proton Pump Inhibitors and Risk of Mild Cognitive Impairment and Dementia. J Am Geriatr Soc. 2017 Sep;65(9):1969-1974. doi: 10.1111/jgs.14956. Epub 2017 Jun 7.
PubMed 28590010
Poea-Guyon S, Ammar MR, Erard M, Amar M, Moreau AW, Fossier P, Gleize V, Vitale N, Morel N. The V-ATPase membrane domain is a sensor of granular pH that controls the exocytotic machinery. J Cell Biol. 2013 Oct 28;203(2):283-98. doi: 10.1083/jcb.201303104.
PubMed 24165939
Wang D, Hiesinger PR. The vesicular ATPase: a missing link between acidification and exocytosis. J Cell Biol. 2013 Oct 28;203(2):171-3. doi: 10.1083/jcb.201309130.
PubMed 24165933
Glebov OO. Understanding SARS-CoV-2 endocytosis for COVID-19 drug repurposing. FEBS J. 2020 Sep;287(17):3664-3671. doi: 10.1111/febs.15369. Epub 2020 Jun 2.
PubMed 32428379
Ragia G, Manolopoulos VG. Inhibition of SARS-CoV-2 entry through the ACE2/TMPRSS2 pathway: a promising approach for uncovering early COVID-19 drug therapies. Eur J Clin Pharmacol. 2020 Dec;76(12):1623-1630. doi: 10.1007/s00228-020-02963-4. Epub 2020 Jul 21.
PubMed 32696234
Cure E, Cumhur Cure M. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers may be harmful in patients with diabetes during COVID-19 pandemic. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):349-350. doi: 10.1016/j.dsx.2020.04.019. Epub 2020 Apr 15.
PubMed 32311651
Duwal S, Schutte C, von Kleist M. Pharmacokinetics and pharmacodynamics of the reverse transcriptase inhibitor tenofovir and prophylactic efficacy against HIV-1 infection. PLoS One. 2012;7(7):e40382. doi: 10.1371/journal.pone.0040382. Epub 2012 Jul 11.
PubMed 22808148
Bradley BT, Bryan A, Fink SL, Goecker EA, Roychoudhury P, Huang ML, Zhu H, Chaudhary A, Madarampalli B, Lu JYC, Strand K, Whimbey E, Bryson-Cahn C, Schippers A, Mani NS, Pepper G, Jerome KR, Morishima C, Coombs RW, Wener M, Cohen S, Greninger AL. Anti-SARS-CoV-2 Antibody Levels Measured by the AdviseDx SARS-CoV-2 Assay Are Concordant with Previously Available Serologic Assays but Are Not Fully Predictive of Sterilizing Immunity. J Clin Microbiol. 2021 Aug 18;59(9):e0098921. doi: 10.1128/JCM.00989-21. Epub 2021 Aug 18.
PubMed 34165323
Graham RL, Baric RS. Recombination, reservoirs, and the modular spike: mechanisms of coronavirus cross-species transmission. J Virol. 2010 Apr;84(7):3134-46. doi: 10.1128/JVI.01394-09. Epub 2009 Nov 11.
PubMed 19906932

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Severe Acute Respiratory Syndrome-related Coronavirus trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cardiac Transfer of SARS-CoV-2 Spike Protein Circulation Techniques - Medicine Induced Hemodialysis on "Vaccinated" Immune Attacks
ClinicalTrials.gov ID: NCT05711810
Acronym / sponsor ID: SARSCoVVaxPoison
Conditions: Severe Acute Respiratory Syndrome-related Coronavirus, Renal Dialysis, Vaccines, Myocarditis Allergic, Infection Viral
Keywords: immune infection, neural infection, spike 2 protein, poison, SARS-CoV-2, precarditis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1 participants (actual)
Lead sponsor: Yang I. Pachankis
Study start: 2 Jan 2023 (actual)
Primary completion: 10 Jan 2023 (actual)
Study completion: 12 Jan 2023 (actual)
First posted: 3 Feb 2023 (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.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The crossover model intervenes on the precarditis and myocarditis happenings on the patient, and evaluates the cause of the symptoms. Basic medicines are tested against the pathogens with the immune responses of the patient.

Arm	Type	Receives
Experiment Participant	Experimental	Drug: Nifedipine 30 MG, Diagnostic Test: Kangzhu BPCB0A-3A, Behavioral: Low Mobility, Drug: Enalapril Maleate 10Mg Tab, Drug: Lansoprazole 30Mg Ec Cap, Drug: Metoprolol Succinate, Dietary Supplement: Coenzyme Q10, Dietary Supplement: d-alpha tocopherol acetate, Dietary Supplement: Omega-3, Drug: Duloxetine Hydrochloride 20 MG Oral Capsule, Delayed Release, Drug: Superoxide DismutaseCOVID-19 recombined vaccinated, 3 dose, no intervention. Nifedipine, oral, 30 mg per day for 2 days, active comparative. Angiotensin-converting enzyme inhibitor, oral, gradually increase to 20 mg per day at night. Beta blocker, oral, 23.75 - 95 mg per day in the morning. Proton-pump inhibitor, oral, 30 mg per day. Duloxetine hydrochloride, oral, placebo, 20 mg per day before sleep. Acetaminophen (sham comparator), oral, 250 mg four times per day for 8 days. Cefuroxime (sham comparator), oral, 100 mg twice per day for 6 days. Papaverine, oral, low-dosage in coughing pills for 4 days. Superoxide Dismutase (active comparator), oral, to be introduced. Bafilomycin A1 (active comparator), oral, 100 ug per kilogram per day, unlikely to be introduced for lack of funding.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

No mRNA vaccinated poisoning have been included currently, but scientific evidence suggest the methods of vaccination are irrelevant to the conditions. It is theorized that the more advanced the vaccine production technology, the deeper the poisoning.

Key exclusion criteria (2 listed)

healthy individuals with no myocarditis or unvaccinated without infection by SARS-CoV series
persons with diabetes (Paxlovid and PrEP treatments can be applied according to availability)

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
Nifedipine 30 MGAlso: Nifedipine Control-release TabletsDue to initial availability of drugs and the intensities of the patient's symptoms, Nifedipine was used for initial intervention in preventing acute myocarditis from happening.	Drug	Experiment Participant
Kangzhu BPCB0A-3AAlso: Heart MonitorThe diagnostic test has been used to confirm objective parameters to guide the intervention drug dosages and accessing the risks in sudden death and long term adverse effects.	Diagnostic test	Experiment Participant
Low MobilityThe behavioral intervention aimed at reducing the risks of sudden and strong blood flows in the patient's system.	Behavioural	Experiment Participant
Enalapril Maleate 10Mg TabThe intervention aims to reduce the vein flows in Diastolic Blood Pressure, and the risks in blood clot formation and internal vein scratch bleeding.	Drug	Experiment Participant
Lansoprazole 30Mg Ec CapThe intervention aims to server the allergy-inducing proteins to induce renal hemodialysis.	Drug	Experiment Participant
Metoprolol SuccinateMetoprolol Succinate is used to control the cardiac artery flow amounts and stabilize the patient's heart rate.	Drug	Experiment Participant
Coenzyme Q10200 mg per day is used for supplement with the cardiac interventions.	Dietary supplement	Experiment Participant
d-alpha tocopherol acetateThe 268 mg twice per day dietary healthcare is the patient's usual daily use.	Dietary supplement	Experiment Participant
Omega-3The 900 mg twice per day dietary healthcare is the patient's usual daily use.	Dietary supplement	Experiment Participant
Duloxetine Hydrochloride 20 MG Oral Capsule, Delayed ReleaseAlso: NeurodiverseDuloxetine hydrochloride is used for the patient's neurodiverse conditions.	Drug	Experiment Participant
Superoxide DismutaseSuperoxide Dismutase is used to substitute the missing of antiviral drugs.	Drug	Experiment Participant

Primary outcome

Heart Rate
Time frame: 1 day
The heart rate is monitored daily, and the primary goal is to stabilize the patient's heart rate.
Electrocardiogram
Time frame: 20 days
Electrocardiogram reflects the blood pressure management on the patient's health outcome and potential risks.
Platelet Distribution
Time frame: 10 days
Platelet distribution is measured to determine the viral induced blood-borne pathogen in the physiological responses of the patient.
Mean Platelet Volume
Time frame: 10 days
MPV is measured to determine the risks in blood clot and internal vein scratches in the patient.
Eosinophil Absolute Number
Time frame: 10 days
Eosinophil Absolute Number is measured to determine the intensities of infection in the patient.
Basophil Absolute Number
Time frame: 10 days
Basophil Absolute Number is measured on the counteraction of the patient's immune system integrities against the rapid acidification of the viral infection.

1 secondary outcome

Cardiac Enzymes
Time frame: 10 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
Background: PubMed 35420469Liu X, Mostafavi H, Ng WH, Freitas JR, King NJC, Zaid A, Taylor A, Mahalingam S. The Delta SARS-CoV-2 Variant of Concern Induces Distinct Pathogenic Patterns of Respiratory Disease in K18-hACE2 Transgenic Mice Compared to the Ancestral Strain from Wuhan. mBio. 2022 Jun 28;13(3):e0068322. doi: 10.1128/mbio.00683-22. Epub 2022 Apr 14.
Background: PubMed 32287546Wu Zhang X, Leng Yap Y. Structural similarity between HIV-1 gp41 and SARS-CoV S2 proteins suggests an analogous membrane fusion mechanism. Theochem. 2004 May;677(1):73-76. doi: 10.1016/j.theochem.2004.02.018. Epub 2004 Apr 2.
Background: PubMed 33024307Hu B, Guo H, Zhou P, Shi ZL. Characteristics of SARS-CoV-2 and COVID-19. Nat Rev Microbiol. 2021 Mar;19(3):141-154. doi: 10.1038/s41579-020-00459-7. Epub 2020 Oct 6.
Background: PubMed 33519802Xavier LL, Neves PFR, Paz LV, Neves LT, Bagatini PB, Timmers LFSM, Rasia-Filho AA, Mestriner RG, Wieck A. Does Angiotensin II Peak in Response to SARS-CoV-2? Front Immunol. 2021 Jan 14;11:577875. doi: 10.3389/fimmu.2020.577875. eCollection 2020.
Background: PubMed 29755512Ortiz-Guerrero G, Amador-Munoz D, Calderon-Ospina CA, Lopez-Fuentes D, Nava Mesa MO. Proton Pump Inhibitors and Dementia: Physiopathological Mechanisms and Clinical Consequences. Neural Plast. 2018 Mar 21;2018:5257285. doi: 10.1155/2018/5257285. eCollection 2018.
Background: PubMed 21172605Tabares L, Betz B. Multiple functions of the vesicular proton pump in nerve terminals. Neuron. 2010 Dec 22;68(6):1020-2. doi: 10.1016/j.neuron.2010.12.012.
Background: PubMed 28590010Goldstein FC, Steenland K, Zhao L, Wharton W, Levey AI, Hajjar I. Proton Pump Inhibitors and Risk of Mild Cognitive Impairment and Dementia. J Am Geriatr Soc. 2017 Sep;65(9):1969-1974. doi: 10.1111/jgs.14956. Epub 2017 Jun 7.
Background: PubMed 24165939Poea-Guyon S, Ammar MR, Erard M, Amar M, Moreau AW, Fossier P, Gleize V, Vitale N, Morel N. The V-ATPase membrane domain is a sensor of granular pH that controls the exocytotic machinery. J Cell Biol. 2013 Oct 28;203(2):283-98. doi: 10.1083/jcb.201303104.
Background: PubMed 24165933Wang D, Hiesinger PR. The vesicular ATPase: a missing link between acidification and exocytosis. J Cell Biol. 2013 Oct 28;203(2):171-3. doi: 10.1083/jcb.201309130.
Background: PubMed 32428379Glebov OO. Understanding SARS-CoV-2 endocytosis for COVID-19 drug repurposing. FEBS J. 2020 Sep;287(17):3664-3671. doi: 10.1111/febs.15369. Epub 2020 Jun 2.
Background: PubMed 32696234Ragia G, Manolopoulos VG. Inhibition of SARS-CoV-2 entry through the ACE2/TMPRSS2 pathway: a promising approach for uncovering early COVID-19 drug therapies. Eur J Clin Pharmacol. 2020 Dec;76(12):1623-1630. doi: 10.1007/s00228-020-02963-4. Epub 2020 Jul 21.
Background: PubMed 32311651Cure E, Cumhur Cure M. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers may be harmful in patients with diabetes during COVID-19 pandemic. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):349-350. doi: 10.1016/j.dsx.2020.04.019. Epub 2020 Apr 15.
B6.Cg-Tg(K18-ACE2)2Prlmn/JLink provided by the sponsor.
Proton Pump InhibitorsLink provided by the sponsor.
SARS CoV 2 Spike Antibody, IgGLink provided by the sponsor.
Angiotensin Converting Enzyme Inhibitors (ACEI)Link provided by the sponsor.
Low basophil count in the bloodLink provided by the sponsor.
Normal basophil count in the bloodLink provided by the sponsor.
Individual participant dataSharing planned: Yes. The emergent intervention started with the PI's research into the virology and post-vaccination adverse effects. The plan was improvised and adjusted accordingly. Statistical analysis was mainly physiological with relation to the virological inductions from the patient's symptomatic responses.

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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?

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 1 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: finished, as of the sponsor's last update on 3 Feb 2023. 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 China. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Heart Rate (time frame: 1 day). The study lists 6 primary outcomes in all. 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 NCT05711810, which also lists 20 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 3 Feb 2023.