COVID-19 Resources & Support

The ACMA recognizes that this is a very difficult time for everyone around the world. The Covid-19 pandemic is creating disruptions in healthcare systems at an unprecedented scale.

We are committed to supporting the life sciences community and the wider healthcare ecosystem in fighting Covid-19.

What is ACMA doing?

COVID-19 Task Force

The ACMA has convened a COVID-19 task force made up of leaders from the pharmaceutical/biotech industry, academia and medicine to focus on the burgeoning needs among the medical affairs/MSL community in the COVID-19 “new normal.”

Financial Assistance

We recognized that many professionals have had to deal with pay cuts, lay offs and other challenging economic hardships. The ACMA will work with you to offer flexible payment plans. Please inquire for more details by contacting us at info@medicalaffairsspecialist.org

Free COVID-19 Course

The ACMA has provided a free COVID-19 course which offers deeper insights and learning for those interested in better understanding the various aspects of the infection. Click on the link below to access the course.

Medical Affairs COVID-19 Initiative

The ACMA has received a large number of requests from companies interested in using this time to Board Certify their medical affairs/MSL teams through the Board Certified Medical Affairs Specialist (BCMAS) program. During the pandemic, the ACMA will donate a portion of the proceeds received from any organization to help healthcare providers and workers in cities ravaged by COVID-19. Email us to learn more.

Donating to Food Banks

Many families are struggling to meet basic needs such as food and shelter during the pandemic. The ACMA will be organizing a way for our industry partners to donate to food banks to help those in need. More information to follow.

ACMA Webinar: Medical Affairs Adapts to the Covid19 Crisis

Watch Webinar & Download Slide Deck

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COVID-19 Resources

We’ll use this page to provide you with the latest information that we can confirm with reputable sources. If you have updates that you believe should be included here, please let us know through our LinkedIn page or by email at research@acmainfo.org .

Centers for Disease Control and Prevention (CDC)

Summary of FDA Guidance to Industry on Clinical Development during COVID-19 Pandemic

  • The ultimate purpose of the guidance is to support the clinical trial sponsors in regards to clinical trials currently being conducted while still maintaining compliance to GCP, trial participant safety and trial integrity
  • Challenges that may arise include: quarantines, site closures, travel limitations, interruptions to supply chain of investigational product, or COVID-19 infection in clinical trial staff or participants
  • These challenges will result in deviation from study protocols and FDA recognizes modifications may need to be made
  • Factors that will influence the level of measures taken include region where the study is conducted, the disease state, trial design, etc.

    Considerations for Ongoing Trials:

    • Safety of trial participants is paramount - decisions must be made on whether continuation of the study drug, continuing recruitment, and changes to patient monitoring are modifications that are in the patient’s best interest and be informed of any changes
    • Quarantines or travel limitations may prevent participants from going to the investigational site for protocol-specified visits – in these situations sponsors could consider alternative methods for safety assessments
    • Additional safety monitoring (withdrawal symptoms) may be necessary for participants who can no longer access investigational product and/or site
    • If COVID-19 screening become mandated by health care system it does not need to be reported as an amendment to the protocol
    • Sponsors are encouraged to engage IRB/IEC as early as possible regarding changes to protocol due to COVID-19, however, if the change is to protect well-being of the participant (e.g. limit COVID-19 exposure) the changes can be implemented with IRB approval or before filing amendment to IND or IDE, required to be reported after
    • Sponsors and clinical investigators must report the reason for contingency measures implemented, duration of the changes, and which participants were impacted and how they were impacted
    • Important to capture specific information in case report form explaining the basis of missing data and how that missing data relates to COVID (e.g. missed study visits or discontinuations)
    • Investigational products that are self-administered can be securely delivered to participants; if administered by HCP alternative method can be implemented (e.g. home nursing)
    • Consultation with appropriate review division recommended regarding protocol modifications related to collection of efficacy endpoints; must document situations where efficacy endpoints aren’t collected and relationship to COVID
    • Sponsors should address in statistical analysis plan how protocol deviations due to COVID will be handled in prespecified analyses
    • Consider using central and remote monitoring of clinical trial sites
  • For trials impacted by COVID sponsor should include in appropriate sections of clinical study report:
    • Contingency measures implemented and analyses and discussions regarding the impact of these measures
    • All participants effected by COVID-19-related study disruptions
    • It is important to make efforts to minimize the impact on trial integrity and documenting reasons for protocol deviations

To access complete FDA guidance, please click here.

COVID-19 News Alert

Stay Informed: Sign up for our COVID-19 news alert

Potential Treatment Options for COVID-19

  • At present clinical management includes infection prevention and control measures and supportive care, including supplementary oxygen and mechanical ventilatory support when indicated
  • Remdesivir
    • Recently received orphan drug approval.
    • An investigational IV drug with broad antiviral activity that inhibits viral replication through premature termination of RNA transcription and has in-vitro activity against SARS-CoV-2 and in-vitro and in-vivo activity against related betacoronaviruses
    • Ways for patients to access: enrollment in NIH double blind placebo controlled study, two phase III randomized open label trials, Compassionate use to individuals who cannot access the trials. Although company is currently limiting to pregnant women and those under 18 years of age.
  • Hydroxychloroquine and Chloroquine
    • Chloroquine has been used for malaria treatment and chemoprophylaxis, and hydroxychloroquine is used for treatment of rheumatoid arthritis, systemic lupus erythematosus and porphyria cutanea tarda
    • Both have in-vitro activity against SARS-CoV, SARS-CoV-2, and other coronaviruses, with hydroxychloroquine having relatively higher potency against SARS-CoV-2
    • Based upon limited in-vitro and anecdotal data, they are currently recommended for treatment of hospitalized COVID-19 patients in several countries
    • Hydroxychloroquine is currently under investigation in clinical trials for pre- or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19.
    • Dosing is anecdotal – there is no actual dosing recommendation

Companies Developing Drugs for COVID

  • Was initially developed as a possible treatment for Ebola and was sidelined in favor of other treatments and vaccines. Currently, doesn’t have approval for any indication by any regulatory body
  • There is an NIH study as well 2 Gilead-sponsored studies
  • Randomized, open label, Phase III Clinical Trials underway to evaluate in moderate and severe cases of COVID
    • Started enrolling in March, results expected in May
  • Started randomized, double-blind, placebo-controlled, phase II/III trial to test as treatment for patients who have been hospitalized
  • Aim is to evaluate if it reduces fevers and need for supplemental oxygen
  • Early results from a small 21-person trial in China that have not been peer-reviewed found that COVID-19 patients reported reductions in fever and 7% of them had a reduced need for supplemental oxygen within days of starting treatment.
  • Phase III clinical trial initiated as treatment for patients with COVID-19 who have been hospitalized with severe pneumonia
  • Will begin enrollment in early April 2020
  • plans to examine patient mortality and need for mechanical ventilation or an intensive care unit stay among other primary and secondary endpoints.
  • The trial is in partnership with BARDA.

COVID-19 Updates

  • Study of 16 patients with COVID-19 who were treated at the Treatment Center of PLA General Hospital in Beijing between January 28 and February 2020
  • Half of the patients (8/16) were viral positive even after resolution of their symptoms
    • Major symptoms: fever (14/16), cough (11/16), pharyngalgia (5/16), dyspnea (2/16)
    • Range: 1 to 8 days after the resolution of symptoms (Median 2.5 days)
    • Study population had relatively mild symptoms, so results may be longer for severe patients
  • Patient could infect their close contacts even after “apparent recovery” from the infection

Published: March 27, 2020

  • Research by Lydia Bourouiba, MIT professor
  • Gas cloud and pathogen-bearing droplets of all sizes can travel 23 to 27 feet
  • Recommendations for social distancing of 3 to 6 feet may be an underestimation
  • “There is an urgency in revising the guidelines currently being given by the WHO and the CDC on the needs for protective equipment, particularly for the frontline health care workers”

Published: March 26, 2020

  • Methods
    • Collected individual-case data for COVID-19 patients in Hubei, mainland China (until Feb 8,2020) and outside of mainland China (until Feb 25, 2020)
  • Findings
    • Mean duration of onset of symptoms to death: 17.7 days
    • Mean duration of hospital discharge: 24.7 days
    • Fatality rate in China
      • 0.32% in age < 60
      • 6.4% in ≥ 60 years old
      • up to 13.4% in > 80 years old
    • Fatality rate outside of China
      • 1.4% in < 60 years old
      • 4.5% in ≥ 60 years old
    • Estimates of proportion of infected individuals likely to be hospitalized increased with age (18.4% in ≥ 80 years old)

Published: March 30, 2020

  • Austrian officials announced that they were making the wearing of masks in supermarket mandatory
    • Masks to be distributed in Austria are below medical grade and goal is to prevent the wearer from spreading virus to others
  • WHO still recommends people to not wear face masks unless they are sick with COVID-19 or caring for someone who is sick

Published: March 30, 2020

  • FDA approves Battelle technology to sterilize N-95 masks, being able to reuse masks

Published: March 29, 2020

Key Points
  • Based on scientific evidence, it is reasonable to believe that chloroquine and hydroxychloroquine may be effective in treating COVID-19, and that potential benefits outweigh the known and potential risks
  • There is no adequate, approved, and available alternative to the emergency use of chloroquine and hydroxychloroquine
  • Chloroquine phosphate and hydroxychloroquine must be administered by a healthcare provider pursuant to a valid prescription of a licensed practitioner
  • Chloroquine phosphate and hydroxychloroquine sulfate may only be used to treat adult and adolescent patients who weigh 50 kg or more and are hospitalized with COVID-19
  • Suggested Doses
    • Chloroquine: 1g of chloroquine on day one, followed by 500 mg daily for 4 to 7 days of total treatment based on clinical evaluation
    • Hydroxychloroquine: 800 mg of hydroxychloroquine on day one, followed by 400 mg daily for 4 to 7 days of total treatment based on clinical evaluation
  • Contraindications: prolonged QT interval at baseline or at increased risk for arrythmia

Letter of Approval on March 28, 2020

  • FDA Authorized the emergency use of Bodysphere Inc’s test that can detect the coronavirus in nearly 2 minutes
  • Administered like a glucose test
  • Designed for use strictly by medical professionals
  • Nearly half of Iceland’s tests have been conducted by biopharma company deCODE genetics, focusing on the wider population
  • DeCODE has tested about 9,000 self-selected people so far
  • Fewer than 1% of the tests came back positive for the virus
  • Around 50% of those who tested positive said they were asymptomatic
  • NEW ESTIMATE shows 25% to 50% of coronavirus carriers don’t feel sick and can infect others
  • Try not to touch face while trying to adjust masks
  • Save the N95 masks for healthcare workers who need them
  • Social distancing is still necessary while wearing a face covering
  • COVID Symptom Tracker app
  • 26% of the 1.5 million app users between March 24-29 2020 reported one or more symptoms through the app
    • 1,702 reported having been tested for COVID-19, with 579 positive and 1,123 negative results
  • 59% of COVID-19 positive patients reported loss of smell and taste, compared with only 18% of those who tested negative
  • Symptoms that could predict COVID-19: loss of smell and taste, fever, persistent cough, fatigue, diarrhea, abdominal pain and loss of appetite
  • 9 young to middle-aged and otherwise healthy patients
  • Patients received treatment for mild upper respiratory symptoms
  • Shedding (ability to expel or excrete the virus) of COVID-19 in the upper respiratory tract is most efficient in the early stages of the disease, when symptoms are still mild
  • Results showed high levels of COVID-19 replication in the upper respiratory tract in the first week of symptoms for all patients (peak at 7.11 x 108 RNA copies per throat swab, day 4)
  • 2 patients continued to show high viral levels until the 10th or 11th day

Published: April 1st 2020

  • Persons with underlying health conditions such as diabetes mellitus, chronic lung disease, and cardiovascular disease, appear to be at higher risk for severe COVID-19- associated disease than persons without these conditions
  • 7,162 patients with data on underlying health conditions and other known risk factors
  • 2,692 (37.6%) patients had one or more underlying health condition or risk factor
  • The percentage of COVID-19 patients with at least one underlying health condition or risk factor was higher among those requiring intensive care unit (ICU) admission (358 of 457, 78%)
  • Those requiring hospitalization without ICU admission (732 of 1,037, 71%) vs those who were not hospitalized (1,388 of 5,143, 27%).
  • According to a report by Shanghai Medical Association, high dose IV vitamin C may improve lung function in hospitalized people with COVID-19
  • There is no evidence that oral vitamin C supplements will help treat or prevent COVID-19
  • If taking supplement, don’t take more than 2,000 mg per day
  • Researchers from the Murdoch Children’s Research Institute in Australia (MCRI) began organizing a trial to investigate whether the tuberculosis (TB), bacille Calmette-Guerin (BCG), might offer some protection against COVID-19
  • Trial of the vaccine on around 4,000 frontline medical staff at hospitals across Australia
  • A previous study showed that BCG at birth may decrease hospitalization due to respiratory infection and sepsis
  • Research showed that social distancing measures implemented in China prevented more than 700,000 COVID-19 cases from developing outside of Wuhan between January 23 — when Chinese officials imposed a nationwide travel ban — and February 19
  • The researchers were able to examine the movements of 4.3 million people as they moved away from Wuhan between January 11 and January 23
  • Self-reported data of 1,356 adults in United Kingdom
  • Study showed 73% reduction in the average daily number of contacts observed per participant (10.8 to 2.9)
  • Estimated that it is sufficient to reduce R0 from 2.6 prior to lockdown to 0.62 after the lockdown based on all types of contact
  • 0.37 for physical contacts only
  • R0: the reproduction number – to describe the intensity of an infectious disease outbreak
  • This article encourages that social distancing and hygiene measures can cut off the number of people that COVID-19 can affect
  • Significant portion of individuals with COVID-19 are asymptomatic, and can still transmit the virus to others
  • CDC recommends wearing cloth face coverings in public settings where other social distancing measures are too difficult to maintain (grocery stores and pharmacies), especially in areas of significant community-based transmission
  • 6-feet social distancing remains important to slowing the spread of the virus
  • Surgical masks or N-95 masks should still be reserved for healthcare workers
  • A French study with 7 men and 4 women with a mean age of 58.7 years, 8 had significant comorbidities associated with poor outcomes
  • Within 5 days, one patient died
  • 8/10 patients still positive for COVID-19 after 5 days of hydroxychloroquine and azithromycin combination therapy
  • This study found no evidence of a strong antiviral activity or clinical benefit of the combination of hydroxychloroquine and azithromycin for severe COVID-19 cases
  • 4-year-old tiger, called Nadia, is thought to be the first animal to have confirmed COVID-19 case in the United States
  • Nadia and six other tigers and lions were symptomatic with a dry cough
  • Test was confirmed by the USDA’s National Veterinary Services Laboratory
  • There are no reports of pets becoming sick with COVID-19 in the United States, but it is still recommended that people sick with COVID-19 limit contact with animals

Others at risk of COVID-19:

We currently DO NOT know…
  • If pregnant women have a greater chance of getting sick from COVID-19 than the general population
  • If pregnant women are more likely to have severe illness from COVID-19
  • If COVID-19 would cause problems during pregnancy or affect the health of the baby after birth
However, pregnant women experience changes in their bodies that may increase their risk of some infections, so it important for pregnant women to protect themselves from illnesses – How?
  • Cover your cough
  • Avoid people who are sick
  • Clean your hands often using soap and water or alcohol-based hand sanitizer
Breastfeeding
  • We currently DO NOT know whether COVID-19 can be transmitted via breast milk
  • Whether and how to start or continue breastfeeding should be determined by the mother in coordination with her family and healthcare providers
A mother with confirmed COVID-19 should take precautions to avoid spreading the virus to her infant
  • Wash hands before touching the infant
  • Wear facemask while feeding at the breast
  • Wash hands before touching any pump or bottle parts
  • If possible, consider having someone who is well feed the expressed breast milk to the infant
Heighted Risk Factors
  • Lack of housing contributes to poor health outcomes
  • Sleeping outdoors often does not provide protection from the environment, quick access to hygiene, and sanitation facilities, or connection to healthcare
Prevention measures
  • Do not clear encampments unless individual housing units are available. Clearing encampments can cause people to disperse throughout the community which may increase the chance of disease spreading
  • Encourage people to set up tents/sleeping quarters with at least 12 feet x 12 feet of space per individual
  • Ensure nearby restroom facilities have functional water taps, and are stocked with hand hygiene materials and bath tissues