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Treatment, Vaccination and Ongoing Studies

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A new surfacing pandemic, COVID19 is still a new disease with no definitive cure or vaccine

Trials of different types of treatments and vaccinations are still being tested to this day, with promising outcomes yet inconclusive.

Our mission as a team is to follow up on the recent evidence based updates of treatment/vaccines newly used or created to fight COVID19 and share the information with the public in simplified forms to give an idea about what is being recently tested and its eligibility for use or not.

Hospital Care

It consists of providing:

  • Supportive care
  • Patients with severe disease often need oxygenation support. High-flow oxygen and noninvasive positive pressure ventilation have been used.
  • Patients who develop ARDS may need intubation with mechanical ventilation

Medication update

Glucocorticoids

  • WHO and CDC recommends against the use of glucocorticoids in patients with COVID-19 pneumonia infection
  • Exceptions: exacerbation of COPD

NSAIDs

  • EMA (European Medicine Agency) and WHO recommend the use of NSAIDs only when clinically indicated such as in patients who are chronically taking them. Also, if needed, NSAIDs should be given as the lowest effective dose.
  • However, acetaminophen is the preferred antipyretic agent.

What’s new? March 2020 update

Remdesivir

  • Use of Remdesivir has been described in case series; but the systemic evaluation of the clinical impact of it on COVID-19 Patients has not been published.
  • The use of Remdesivir may be allowed through compassionate use for pregnant women or children less than 18 years of age with confirmed COVID-19 and severe manifestations of disease.

Hydroxychloroquinine

  • Both Chloroquine and Hydroxychloroquine have been reported to inhibit SARS-CoV-2 in vitro, although hydroxychloroquine appears to have more potent antiviral activity.
  • Clinical data is limited and their efficacy is unknown.
  • Use of Chloroquine is included in treatment guidelines from China's National Health Commission and was reportedly associated with reduced progression of disease and decreased duration of symptoms, but the data have not been published yet.
  • In the United States, the FDA issued an emergency use authorization to allow the use of these agents in adolescents or adults hospitalized for COVID-19 when participation in clinical trials is not feasible:
  • Hydroxychloroquine 800 mg on day 1 then 400 mg daily and chloroquine 1 g on day 1 then 500 mg daily, each for four to seven days total depending on clinical response

Interlukin-6 pathway inhibitors

  • Treatment guidelines from China's National Health Commission include tocilizumab for patients with severe COVID-19 and elevated IL-6 levels.

Convalescent plasma

  • In the United States, because since COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product.
  • The FDA is only accepting its use in emergency investigational new drug application for patients with severe or life-threatening COVID-19.
  • Health care providers or acute care facilities would instead obtain COVID-19 convalescent plasma from an FDA-registered blood establishment.

NSAIDs

  • Favipiravir: RNA polymerase inhibitor
  • It is available in some Asian countries for treatment of Influenza. It is being evaluated in clinical trials for the treatment of COVID-19
  • Lopinavir-ritonavir: Combined protease inhibitor, used for HIV infection.
  • It appears to have some activity against SARS-CoV in vitro and against MERS-CoV in animal studies.
  • It appears to have little or no infection in the treatment of SARS-CoV-2 infection.

Vaccinations

What’s new?

  • Numerous vaccine candidates are being evaluated for prevention of COVID-19. The first vaccine to undergo preliminary study in humans in the United States uses a messenger RNA platform to result in expression of the viral spike protein in order to induce an immune response
  • Clinical trials are also being conducted in the United States and elsewhere to evaluate the safety and efficacy of post-exposure drug prophylaxis against COVID-19
  • No agent is known to be effective in preventing infection

Investigational vaccines

Vaccine Comments
INO-4800 (Inovio Pharmaceuticals) Phase 1 human clinical trials are expected to begin in April 2020. In addition, Inovio has received a grant from the Bill and Melinda Gates Foundation to accelerate testing and scale up a smart device (Cellectra 3PSP) for large-scale intradermal vaccine delivery. Phase 1 study will enroll up to 40 healthy adult volunteers in Philadelphia, PA (at the Perelman School of Medicine at the University of Pennsylvania), and Kansas City, MO (at the Center for Pharmaceutical Research), where screening of potential participants has already begun.
mRNA-1273 (Moderna Inc) A phase 1 study has been initiated in 45 healthy volunteers as of March 16, 2020 at Kaiser Permanente Washington Health Research Instituted in Seattle.
mRNA vaccine (CureVac) Vaccine is in development and not yet ready for human testing as of March 16, 2020.
mRNA vaccine BNT162 (BioNTech and Pfizer) Joint development of BioNTech’s mRNA-based vaccine candidate initiated.
COVID-19 S-Trimer (GlaxoSmithKline [GSK] and Clover Biopharmaceuticals) Preclinical development is underway using GSK’s adjuvants (compounds that enhance vaccine efficacy) and Clover’s proprietary proteins, which stimulate an immune response.
XWG-03 (GlaxoSmithKline and Xiamen Innovax collaboration) GSK will provide Innovax with its adjuvant system for preclinical vaccine evaluation.
Vaccine with CpG 1018 adjuvant (Dynavax and Clover Biopharmaceuticals) Dynavax is providing Clover with adjuvant for its protein-based coronavirus vaccine candidate.
SARS-CoV-2 vaccine (Johnson & Johnson [J&J]) Partnering with the Biomedical advanced Research and Development Authority (BARDA) to utilize Janssen’s AdVac and PER.C6 technologies, which provide rapid upscale production of an optimal vaccine candidate.
rDNA vaccine (Sanofi) Collaborating with BARDA to develop a vaccine using their recombinant DNA platform.
Saponin-based Matrix-M adjuvant vaccine (Novavax) Stimulates the entry of antigen-presenting cell into the injection site and enhances antigen presentation in local lymph nodes to boost the immune response.
Live-attenuated vaccine (Codagenix) Codagenix, a clinical-stage biotechnology company, is collaborating with the Serum Institute of India to co-develop a live-attenuated vaccine.
PCR-based DNA vaccine (Applied DNA Sciences and Takis Biotech) The collaboration has designed four COVID-19 vaccine candidates utilizing PCR-based DNA manufacturing systems for preclinical testing in animals.
Intranasal COVID-19 vaccine (Altimmune, Inc) Design and synthesis has been completed and is advancing toward animal testing.
Brilacidin adjuvant vaccine (Innovation Pharmaceuticals) Material Transfer Agreement (MTA) signed with a leading public health-focused US university and top coronavirus expert to evaluate the potential antiviral properties as a defensing adjuvant.
HaloVax (Hoth Therapeutics; Voltron Therapeutics) Collaboration with the Vaccine and Immunotherapy Center of the Massachusetts General Hospital. Use of VaxCelerate self-assembling vaccine platform offers one fixed immune adjuvant and one variable immune targeting to allow rapid development.
PittCoVax (U of Pittsburgh School of Medicine) Vaccine candidate using microneedle transdermal for COVID-19. Testing in mice produced antibodies over a 2-week period. Microneedles are made of sugar, making it easy to mass-produce and store without refrigeration.
Nanoparticle SARS-CoV-2 vaccine (Ufovax) Vaccine prototype development utilizing self-assembling protein nanoparticle (1c-SapNP) vaccine platform technology.