COVID-19 Treatment: Letter of Proposal And Protocol Sent To Gov’t. of Guyana.
Date: September 30, 2022
To: The Hon. Frank Anthony- Minister
Ministry of Health
Lot 1 Brickdam,
Georgetown.
Dear Sir,
It is of great pleasure for me Dr. Martin C. Blair MD, MMSc, a Guyanese at Sunningdale University to engaged in seeking the support and assistance of the Ministry of Health (MOH) for a grant, a sponsor or as a collaborator for the funding in the amount of US$ 1, 489, 260.00 (see budget and attachment). Our request is in support of our Clinical Trial on SARS-CoV-2 Title: Does the addition of MCB3B/CH enhance the effect and efficacy of Baricitinib and Dexamethasone against COVID-19 infection: A comparative phase ll multi-centre, randomized, double-blind trial- in Guyana.
I am Health Researcher registered at The National Health Research Authority (NHRA) in Zambia. As a Guyanese I am committed to advance Guyana to new heights through scientific health research that will place Guyana among the leaders in health research and medicine.
As viral infections remain a major cause of economic loss around the world with an unmet need for novel therapeutic agents, the initiative must lead you to become innovative. This clinical trial is done to (a) confirm the effectivity, safety and efficacy of Baricitinib and Dexamethasone + MCB3B/CH triple therapy for the SARS-CoV-2 virus (b) MCB3B/CH as a single therapy treatment for the COVID-19 and (c) MCB3B/CH Oral and Nasal Spray use as a treatment and prophylact against All SARS-CoV-2 infections.
I am enthusiastic about the clinical trial and am eager for its submission for trial. The research has already been approved by the Sunningdale University Ethics Research Committee (SUERC). Copy will be submitted shortly to The National Health Research Authority (NHRA) and clinical trial to Pan African Clinical Research Trial.
This research and clinical trial is one of nineteen (19) research and clinical trials initially planned to be conducted in Zambia, but after careful thought and lexical consideration of what this will mean for Zambia, the enormous benefits for Zambia in terms of international recognition, in the breakthrough of health research and medicine and the potential Income, as a Guyanese, it will be wiser for me to consider Guyana first to receive those benefits over any other country.
Thank you for your consideration on this request. Meanwhile, should you have any questions, please feel free to contact me: Dr. Martin C. Blair MD, MMSc, LLB., the leading Investigator, at martinblair1958@gmail.com.
Sincerely,
Principal Investigator
cc: President
cc: Vice President
cc: Prime Minister
cc: Permanent Secretary
Date: March 31, 2022
Researcher: Dr. Martin C. Blair MD, MMSc, LLB
Institution: Sunningdale University, Lusaka, Zambia
Research Title:
Does the addition of MCB3B/CH enhance the effect and efficacy of Baricitinib and Dexamethasone against COVID-19 infection: A Phase ll multi-centre, randomized, double-blind trial?-in Guyana?
Abstract
In January 2020, the new SARS-CoV-2 coronavirus was identified in China. Since then the World Health Organization (WHO) has added eight new recommendations of drugs to their regimen for the treatment of SARS-CoV-2 infection. The most recent drugs added to their recommended list of guidelines are GSK-Vir’s Sotrovimab and Lilly’s Baricitinib for the treatment of Covid-19. GSK-Vir’s Sotrovimab is recommended to treat individuals with mild or moderate Covid-19 and Lilly’s Baricitinib along with corticosteroids to treat severe or critical Covid-19 patients. This latest advice is an indication that additional options must be perused if we are to defeat this SARS-CoV-2 pandemic. Point to note is that this oral drug Baricitinib, belongs to the therapeutics class of drugs called Janus kinase (JAK) inhibitors used for the prevention of overstimulation of the immune system and for the treatment of rheumatoid arthritis while Sotrovimab is a substitute to a cocktail of monoclonal antibodies. This recent recommendation is inclined to the patient population with immunocompromised underlying conditions such as hypertension, diabetes and obesity and for those who have not received Covid-19 vaccines.
To date in African and around the world, the numbers of cases are increasing exponentially, as various strains of the disease continue to span the world of its similarity and class. Although numerous studies are been conducted to find an effective prophylactic and acceptable medication as a treatment, two years after this infection was discovered the WHO and other Leading Scientist, Researchers and Healthcare Institutions are still limbered as they are currently nowhere close to its future predictions, clarifications and documentations of the true definition of its future infectivity and margin mutational cause. This unusual and highly transmissible infection especially among elderly patients with underlying co-morbidity and patients with a compromise immune system, such as HIV/AIDS some are been hospitalized under mechanical ventilation in an intensive care units. Mortality rate has also skyrocketed among the elderly and people with underlying co-morbidities such as hypertension, chronic lung disease, cardiovascular disease, cancer, diabetes, and other immunosuppressed medical conditions are all at increased risk to be severely infected with (SARS-CoV-2)/COVID-19.
The authorized vaccines have been met mush skepticism for its immunogenicity and safety due to the short time taken for its development and fast track mechanism for its implementation. Point to note are: (a) Although the ongoing pivotal phase for safety and efficacy of the clinical study has been ongoing, the final outcome of the vaccines is far away from its true prediction’s, as the study does not explicitly describe the immunogenicity, reactogenicity and safety in participants with HIV infection and other Heart Diseases; like Cardio Vascular Diseases (CVD) or Coronary Artery Disease (CAD). (b) It is of no doubt that the (SARS-CoV-2) infection has an impact on the immune response to the virus and (c) In the current pandemic situation where access to vaccine is under pressure, flexibility regarding other treatment is imperative and must be swiftly explored if mankind is to survive as human in as a community within society.
Currently in Guyana, there is no effective treatment for COVID-19 as it is around the world. Since the viral load is high in the respiratory tract and airways during COVID-19 infection. Our proposed (RAITC-19) clinical trial is to study whether the combination of three drugs is more effective than taking a single drug to reduce the viral load in the inflammation in the respiratory tract. The two main objectives to this (RAITC-19) study are (1): (a) improve viral eradication from the patient’s body and respiratory tract, (b) to reduce infection, (c) to rapidly improve the patient’s state of health and reduce the risk of viral transmission to others, (d) investigate and put on record the effectiveness and added benefits of MCB3B/CH protocol when administered to patient who are confirmed positive for COVID-19. (e) To confirm and put on record the effectiveness and added benefits of MCB3B/CH if administered as a single or in a combination therapy to confirmed positive COVID-19 patient. From the impressive and astonishing results from patients treated with the MCB3B/CH protocol in both adults and children, with and without co-morbidity and confirmed RT/PCR positive to negative, no more Guyanese and friends of Guyana, should die from (SARS-CoV-2): (a) In Guyana, (b) South America, (c) The Caribbean Islands or (d) Around the World.
Our Mission
Our mission is to help community and society to improve and maintain a healthy lifestyle that will maximize their quality of life.
Research Plan
Specific Aims
In conducting this study, we will accomplish the following specific aims:
Specific Aim 1: to investigate and put on record the safety, effectiveness and added benefits of MCB3B/CH as a single therapy when administered to patient with comorbidities and confirmed positive for COVID-19 by evaluating patients outcomes at day 2 and days 4, especially day 3: a) recovery rate, b) stage of change, c) response rate, d) resolution of symptoms by day 5. All patients will be treated by a well-trained health professional in recommended personal protective equipment (PPE)
Hypothesis 1: Patients treated with MCB3B/CH both as a single or combination therapy should demonstrate a highest recovery rate, highest stages of changes, highest response rate to the treatment and fastest resolution to symptoms within the timeline compare to patients treated with the control Baricitinib and Dexamethasone as a single therapy.
Specific Aim 2: Compare the effectiveness of MCB3B/CH when administered as a combination therapy with Baricitinib and Dexamethasone to patient with comorbidities and confirmed positive for COVID-19 by evaluating patients outcomes at day 2 and days 4, especially day 3: a) recovery rate, b) stage of change, c) response rate, d) resolution of symptoms within timeline. Patients will be treated by a well-trained health professional in recommended personal protective equipment (PPE)
Hypothesis 2: Patients treated with the combination therapy Baricitinib and Dexamethasone +MCB3B/CH should demonstrate the same recovery and resolution of symptoms as patient treated with MCB3B/CH as a single therapy within the timeline.
Specific Aim 3: Compare the effectiveness of MCB3B/CH when administered as a single therapy to patient with comorbidities compared to patient that received Baricitinib and Dexamethasone as a single therapy to patient confirmed positive for COVID-19 by evaluating patients outcomes at day 2 and days 4, especially day 3: a) recovery rate, b) stage of change, c) response rate, d) resolution of symptoms by day 5. Patients will be treated by a well-trained health professional in recommended personal protective equipment (PPE)
Hypothesis 3: Patients with comorbidity treated with MCB3B/CH single or combine therapy of Baricitinib and Dexamethasone+MCB3B/CH should demonstrate to be more effective in the resolution of COVID-19 symptoms within the timeline than those treated with Baricitinib and Dexamethasone as a single therapy.
Background & Significance
Viral infections remain a major cause of economic loss with an unmet need for a novel therapeutic agent. With the onset of global pandemic of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the sharp rise of infection, has greatly impacted existing health infrastructure in Africa. To date it has been relentless in infecting not only those in Africa and Europe, but also people around the world. Mortality and morbidity continues to rise as different and new strains of SARS-COV-2 emerges around the world. Although world class scientist and physicians has increased their efforts to find a cure, to date their efforts have been proven to fall short that which has demonstrated to be a past success. A comprehensive assessment of the global effects of the COVID-19 pandemic in low- and middle-income countries (LMICs) has revealed that COVID-19 has continued to rob communities of essential health services equally as it has deprived society of its successful gains.
The significance to note is that this pandemic has not only disturbed the lives of Guyanese and those in Low, Middle Income Countries (LMICs), but also those of Higher Income Countries (HIC). In a direct or indirect way SARS-COV-2 has affected all related outcomes on every disease and other essential health care services. As of recent some African countries like Zambia has been hit by the much anticipated fourth wave of SARS-COV-2 with an increase in the numbers of cases from 0.7% to 2.5% positivity rate, according to the Ministry of Health, it is high time that a preventive/prophylactic measures is seriously taken into account, so as to avert the spread of the virus and its variants. The misconceptions of vaccines, especially the COVID-19 vaccines would continue to cast doubt among people, just as it has been done in the past with variances, so shall it continue to cast doubt with future variances. On this premise and others that has been mentioned, it warrants an immediate treatment that will satisfy and curbs the ambiguities caused not only by the vaccines but also by SARS-COV-2 virus.
This clinical trial is set out to confirm that there is a treatment for SARS-COV-2 virus which shall be confirmed by the findings at the conclusion of this trial. The proposed intervention treatment will provide the foundation and a platform for physicians and medical learners to treat COVID-19 patients with or without comorbidity. The rationale for this clinical trial is to: a) stop the spreading of Covid-19 infection, b) find a treatment so as to bring an end to the confusions caused by the pandemic, by doing so physicians and healthcare workers will; 1) save lives in the community, 2) save the lives of at risk patients, 3) save the lives of patient with comorbidity 4) restore community, society and the world back to the pre COVID-19 era.
Study Design
The study is designed as a comparative Phase ll multi-centre, randomized, double-blind trial to recruit 300 candidates in three groups, 100 patients assigned to each group. Group A (experimental) will be treated with Baricitinib and Dexamethasone + MCB3B/CH plus Supportive big five therapy. Group B (experimental) will be treated with MCB3B/CH capsules and MCB3B/CH Oral and Nasal Spray plus supportive big five therapy. Group C (control) will be treated with Baricitinib and Dexamethasone standard recommended therapy and protocol. RT/PCR testing in 36hrs, 48hrs, 72hrs, 96hrs and 120hrs will be conducted for each group. The treatment will last for 5days/120hrs and patients will be followed for an added 21days.
Setting:
Hospitals, Designated Clinics and Approved COVID-19 Quarantine holding areas throughout Guyana
Study Subjects:
Our primary objective is to study 600 patients who are confirmed by RT/PCR positive for COVID-19, but if funding resource for primary objective cannot be achieved then we will proceed with our secondary objective of 300 patients. Both adults and children aged 12yrs and above. Signed ICF by patients, parent’s or guardian indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study. Pregnant female, intended to get pregnant while on the trial with the experimental treatment, breast feeding or intended to breast feed female. Male and female with co-morbidities of Heart Disease, Liver Disease, Hypercholesterolemia, DM-2, Hypertension, Skin Infections, Lung Infections, Asthmatic patients. Patients on cART, HIV patients with CD4 count <1, Viral load >1000 c/mL are accepted.
Randomization:
Patients will be randomized at emergency room of hospitals as well as at outpatient ambulatory care and clinics, according to routine procedures of recruiting centres. At randomization a treatment ID will be assigned to the patient determined by the holder of the sequence who is situated off site. Once a treatment ID is assigned this must not be re-assigned even in cases of errors.
Primary Outcome Measures:
- The percentage of patient defined as symptom free to be discharged from treatment by day2 and 3 in the experimental arm compared to the control arm.
Secondary Outcome:
- The time taken to treat both experimental and control group by measuring the time of admission of the patient to the time of discharged. 2. The proportion of patients on Baricitinib and Dexamethasone who test positive for covid-19 using PCR testing after day 4 and day 5 compared to patient on MCB3B/CH experimental group A and B on day 2 and 3 and day 5. 3. The time taken for significant reduction of inflammatory markers and viral load in the experimental group A, group B and control group C. 4. Time to resolution of symptoms in all groups
Process Measures:
Patient’s satisfaction with the quality of care in general and satisfaction with the time taken from the start of treatment to the time of being symptom free to be discharged from treatment.
Analyses:
Patient level analyses of main outcome and process measures comparing patients who received treatment from experimental group A and B to those who received the control treatment in group C.
Resources & Environment
The total cost for this project is estimated to be about Seven Hundred and Forty Four Thousand Six Hundred and Sixty Dollars (US$ 1, 489, 260.00). To date we have been self-sponsored. So we are openly seeking resource for this clinical trial from donors, private, public organizations, companies, available government funding for research and clinical trials, partners, grant, individuals and other funders.
The beneficiaries for this clinical trial are (a) Sick (COVID-19) patients with or without co-morbidity, (b) The elderly (c) Patients with communicable and non-communicable diseases e.g. Heart, Liver, Diabetes, Lungs, Prostate, Hypertension, etc. (d) The immunosuppressed (e) Businesses, Communities, Societies and Organizations are all benefactors of this trial.
Timeline
- The time taken to treat both experimental groups from the time of admission of the patient to the time of resolution of symptoms to discharge from treatment will be within 24hrs -96hrs.
- The time taken for significant reduction of inflammatory markers and viral load in experimental group 48hrs.
Hours Days Month
Activity 1-3 1-5 1-5
Patient randomization X
Train medical assistants to recruit patients X
Recruit patients X
Patient counseling in-person X
Patient counseling by phone X
Data collection X
Data analysis X
Prepare publication(s) X
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