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Resources and information on the COVID-19 pandemic with a focus on the intersection with the HIV pandemic

Remembering Gita Ramjee​ - From the MTN

We are writing to share the sad news about the passing of one of our very dearest colleagues, Gita Ramjee. The cause of death is from complications of COVID-19.

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Words cannot express the sorrow we feel. Gita was a tremendous force within the field and was part of the MTN family from day one. As you all know she directed the MRC CTU in Durban for many years, and in May 2019 refocused her efforts toward spending more time with her sons living in London and enjoying her grandson who is about 6 months old. Gita had a tremendous passion for HIV prevention and she cared deeply about addressing the disparities in HIV incidence in young women. It wasn’t too long ago that she wrote in an email, “It has been a long road with many ups and downs but we have forged along with strong determination.” She was always impeccably dressed. She always had a beautiful manicure. She always had a big smile. We will always appreciate her role in the MTN family.

We will miss Gita and wish her family comfort during this time of unfathomable loss.

Stay well, stay safe.

Warmest wishes to all of you in this difficult time.

Sharon Hillier and Jared Baeten


COVID-19 and terminology
Coronavirus disease 2019 (COVID-19) is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. The new virus that causes COVID-19 illness has been named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
According to the World Health Organization: the most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some patients may have aches and pains, nasal congestion, runny nose, sore throat or diarrhea. These symptoms are usually mild and begin gradually. Some people become infected but don’t develop any symptoms and don't feel unwell. Most people (about 80%) recover from the disease without needing special treatment. Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness. People with fever, cough and difficulty breathing should seek medical attention.
Background on coronaviruses from the NIH: “Coronaviruses are a large family of viruses that usually cause mild to moderate upper-respiratory tract illnesses, like the common cold, in people. However, three times in the 21st century coronavirus outbreaks have emerged from animal reservoirs to cause severe disease and global transmission concerns.
There are hundreds of coronaviruses, most of which circulate among animals including pigs, camels, bats and cats. Sometimes those viruses jump to humans—called a spillover event—and can cause disease. Seven coronaviruses are known to cause human disease, four of which are mild: viruses 229E, OC43, NL63 and HKU1. Three of the coronaviruses can have more serious outcomes in people, and those diseases are SARS (severe acute respiratory syndrome) which emerged in late 2002 and disappeared by 2004; MERS (Middle East respiratory syndrome), which emerged in 2012 and remains in circulation in camels; and COVID-19, which emerged in December 2019 from China and a global effort is under way to contain its spread. COVID-19 is caused by the coronavirus known as SARS-CoV-2.
Thanks to research investments into the SARS and MERS outbreaks, NIAID scientists and grantees are better prepared to develop diagnostics, therapeutics and vaccines against COVID-19. Included in those projects are basic research to understand how the virus infects cells and causes disease; adapting platforms used to develop diagnostic tests and vaccines; and evaluating treatments such as broad-spectrum antivirals and potentially monoclonal antibodies.”
 

Note: COVID-19 is an emerging, rapidly evolving situation.

 



The CDC has a FAQ page dedicated to COVID-19: What people with HIV should know.

  • ​The CDC notes that although the risk of serious illness from COVID-19 for people with HIV is not known, people with HIV may have concerns and questions related to their risk. This is an emerging, rapidly evolving situation and the CDC will provide updated information as it becomes available.

 

AIDSinfo

The Interim Guidance for COVID-19 and Persons with HIV is now available on the AIDSinfo website. The guidance, which was developed collectively by the U.S. Department of Health and Human Services Antiretroviral and Opportunistic Infections Guidelines Panels, which are working groups of the Office of AIDS Research Advisory Council, is intended for health care providers and persons living with HIV in the United States.

NIH HIV/AIDS Clinical Trials Networks
The NIH HIV/AIDS Clinical Trials Networks (ACTG, HPTN, HVTN, IMPAACT and MTN) have all recently issued guidance on the status of new and ongoing studies. They are all listed here. In general, for most studies, ​opening of new studies will be on hold and screening and enrollment in ongoing studies will be paused. Visits in ongoing studies will be continued, subject to local challenges or constraints. For the status of ongoing studies, refer to the guidance. Contact your site or network if you have questions about specific ongoing studies. Additional guidance specific to laboratories is posted here​.
 
EMA
From the European Medicines Agency (EMA) and collaboratorsGuidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic. (Version 1- 20/03/2020).
FDA
FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic at: https://www.fda.gov/media/136238/download
 
NIH
Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 (Notice Number: NOT-OD-20-87)at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-087.html
Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19 (Notice Number: NOT-OD-20-86)at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-086.html
NCI
NCI Interim Guidance for Patients on Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program (NCORP).

SAHPRA

SAHPRA Policy on Conduct of Clinical Trials of Health Products During the Current Covid-19 Pandemic. The South African Health Products Regulatory Authority (SAHPRA) is committed to providing timely health products regulatory guidance in support of continuity for stakeholders and appropriate timely regulatory response during the current COVID-19 pandemic. Specifically, this communication provides assistance to sponsors and applicants including clinical research organizations (CROs) in assuring the safety of trial participants, maintaining compliance with current good clinical practice (GCP), and minimising risks to trial integrity during the COVID-19 pandemic. Issued 25 March 2020.

World Health Organization key reference links on HIV-COVID-19:

 

American Academy of HIV Medicine

Considerations & Suggested Practices for Ambulatory HIV Specialty Care During Covid-19 Pandemic.

 

  • As part of the American Academy of HIV Medicine’s commitment to provide relevant and useful information during the COLVID-19 pandemic, please find attached a Spanish translation of the newly released guidance on COVID-19 and HIV care. Many thanks to Centro Ararat and their Chief Medical Officer and Academy member Dr. Iván Meléndez-Rivera for developing and distributing this useful resource.  Click here to view the downloadable PDF.
Infectious Disease Society of America (IDSA) 

From the Infectious Disease Society of America (IDSA) and the HIV Medical Association (HIVMA): COVID-19: Special Considerations for People with HIV (Version: March 18, 2020)

 

From the Infectious Disease Society of the USA (IDSA): a compilation of COVID-related policies and protocols, as well as coverage and payment-related information and will be updated as resources and new information becomes available.

 

IDSA and HIVMA Lead Call for Data-driven Public Health and Medical Responses to COVID-19:
As infectious diseases and HIV specialists on the frontlines of responses to COVID-19 across the country, members of the Infectious Diseases Society of America and its HIV Medicine Association welcome the president's announcement Sunday (March 29, 2020) that he has amended his projected duration for stay-at-home and physical distancing guidelines to last at least through April based on medical and public health guidance. With a letter signed by 60 organizations representing health professionals, patients, and advocates, and with a petition signed by more than 2,000 individuals to date, IDSA and HIVMA are leading a call for President Trump to ensure that all of his administration’s responses to the ongoing public health crises posed by the spread of COVID-19 are based on the most current medical and public health guidance available. As health professionals confronting the grim and tragic consequences of uncontained and escalating outbreaks of a new virus for which no vaccination or proven treatment yet exist, we are urging the President and Vice President Pence to continue to respond, and, where needed and advised, strengthen responses to scientific expertise and to data showing:
  • Continuing needs for rigorous public health measures that include consistent and effective social distancing guidelines, and measures that support and enforce their uniform compliance;
  • For the equipment necessary to protect health workers, treat patients and save lives;
  • And to reinforce responses with meaningful economic, nutritional and educational support for all Americans whose lives and livelihoods are disrupted by efforts to control this pandemic.
The organizational letter and the public petition were presented to the President on March 30, 2020. The IDSA continues to gather signatures on the petition. This is the IDSA link to considering adding your name.

 

HIV Treatment Bulletin (HTB)

 

The 27 March 2020 edition of HIV TREATMENT BULLETIN (HTB) is on the global health crisis related to the new coronavirus (SARS CoV-2) and COVID-2019 and the effect it will have for people living with HIV. HTB notes that “given the rapid pace of information, advice, research and recommendations about COVID-19, many of the links and information might either soon be outdated – or superseded. As with all health information, please check the date. The importance of updating information online, even after it has been published, means that this issue includes many links, rather than using current online text. i-Base also has a COVID-19 page for new links and updates over the coming weeks and months. www.i-Base.info/covid-19The selected links are just a small selection and they will likely only have a limited shelf-life. We have only included research that is available as open access papers. And it is notable that the urgency of the crisis has called for all papers to become open access. Thanks especially to Lynda Dee, Richard Jefferys, Jules Levin, Michael Louella, Jeff Taylor and Nelson Vergel. Community forums include: AIDS Treatment Activist Coalition (ATAC), European AIDS Treatment Group (EATG), ATAC Immune-Based Treatment (ATAC-IBT), International Treatment Preparedness Coalition (ITPC) and the UK Community Advisory Board (UK-CAB).”
 

Positive Women’s Ne​twork-USA

#WeGotThis: To Our PWN Family Regarding the Coronavirus Epidemic (March 13, 2020)

 

POZ Magazine

​From POZ Magazine: What People With HIV Need to Know About the New Coronavirus

What People With HIV Need to Know About the New Coronavirus?

 

 

Tuberculosis and COVID-19

 
The Union published a statement regarding COVID-19 on 13 March 2020. They also have developed answers to a series of Frequently Asked Questions about the intersection between tuberculosis (TB) and COVID-19. These include information about the similarities between the two diseases, and guidance for how COVID-19 affects people on TB treatment or people who have recently recovered from TB. (Version 1, 25 March 2020). 
 
(Note: The mission of the Union is to promote national autonomy within the framework of the priorities of each country by developing, implementing and assessing anti-tuberculosis, lung health and non-communicable disease programmes as well as other public health issues.)

 

Behavioral Health Care Resources

 

COVID-19 Excel spreadsheet (with resources on two tabs)

 

Courtesy of:

Richelle Allen, Ph.D., Assistant Professor

Director, The Safran Center for Psychological Services

Assistant Director of Clinical Training, The New School for Social Research

 

Mental Health Resources

 

The WHO Comprehensive Mental Health Action Plan 2013-2020  is the global plan that sets out the indicators that all WHO Member states have agreed to deliver in order to improve mental health for all.  This plan will be updated over the course of this year and Ministers of Health will approve the new plan for 2021-2030 in May 2021 at the World Health Assembly. 

In the coming weeks and months, the WHO will be leading discussions with governments at regional and country level on the new plan and with stakeholders more broadly. The WHO is also holding two periods of online consultation on the updates to the plan. The first opened March 9 and runs until March 22nd 2020. See here for more information. A second online consultation will be held later this year.

Mental health and COVID-19: WHO is publishing resources on mental health and COVID-19, please visit this link: https://www.who.int/docs/default-source/coronaviruse/mental-health-considerations.pdf?sfvrsn=6d3578af_10.

 

WHO also has a guide to addressing stigma associated with COVID-19: https://www.who.int/docs/default-source/coronaviruse/covid19-stigma-guide.pdf.

 

COVID-19 Potential Therapies​

 

COVID-19 Resources: Experimental Agent Review- Members from the Society of Infectious Diseases Pharmacists have prepared brief, evidence-based reviews of potential pharmacotherapeutic treatment options for COVID-19. These video presentations and handouts will be updated regularly as new data emerge on each of these experimental therapies.

 

COVID-19 vaccine and therapeutic research. The Milken Institute is currently tracking the development of treatments and vaccines for COVID-19 (coronavirus). Per the Milken Institute: "This document contains an aggregation of publicly-available information from validated sources. It is not an endorsement of one approach or treatment over another, but simply a list of all treatments and vaccines currently in development. Given the immediacy of the current public health emergency, we believe it is important to make the data accessible to the public in its current form. This overview will be updated as new findings come to light. We ask that you check this page on a regular basis."

 

There were reports that lopinavir/ritonavir (Kaletra) might have some anti-coronavirus activity. However, a paper published in the New England Journal of Medicine on March 18, 2020 reported that in hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir–ritonavir treatment beyond standard care. An accompanying editorial was published on March 18, 2020, at NEJM.org that provided important context and observations for this and future trials for people with COVID-19 disease.

 

From the Gilead website: Gilead has initiated two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 following the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing. These randomized, open-label, multicenter studies began enrolling patients in March 2020 and will enroll a total of approximately 1,000 patients in the initial phase of the studies, in countries with high prevalence of COVID-19. The first of two studies will evaluate the safety and efficacy of both a 5-day and a 10-day dosing duration of remdesivir, in addition to standard of care, for patients with severe manifestations of COVID-19. The second study will evaluate the safety and efficacy of the same dosing regimens of remdesivir in addition to standard of care for patients with moderate manifestations of COVID-19, compared with standard of care alone. (Accessed March 24, 2020)
 
Interactions with experimental COVID-19 therapies. The Liverpool Drug Interaction Group (based at the University of Liverpool, UK), in collaboration with the University Hospital of Basel (Switzerland) and Radboud UMC (Netherlands), have produced various materials in PDF format to aid the use of experimental agents in the treatment of COVID-19. Please check this site regularly for updates and additional information. 

Stability of SARS-CoV-2 (COVID-19 virus) on Surfaces

 

study published on March 17, 2020 in the NEJM found that aerosol and fomite transmission of SARS-CoV-2 is plausible, since the virus can remain viable and infectious in aerosols for hours and on surfaces up to days (depending on the inoculum shed). This study reinforces the importance of hand washing in addition to social distancing to reduce coronavirus transmission.

 

Webinars of Interest

 
AVAC was joined by Dr. Carl Dieffenbach, Director of the Division of AIDS (DAIDS) at the NIH, and other partners, to answer questions about what we do and don’t know about COVID-19 and HIV, how to track research developments on the HIV front, what this new pandemic might mean for ongoing HIV research, and how the HIV community can contribute to the fight against COVID-19.
 
COVID-19 & HIV Full Meeting (March 24, 2020)
The University of Washington AIDS Clinical Trials Unit’s Community Advisory Board (UW ACTU CAB) held an online meeting on March 24, 2020 focused on the COVID-19 pandemic. Dr. Rachel Bender Ignacio, Associate Director of the UW ACTU, presented and her excellent slides can be downloaded here: https://bit.ly/3bnvGZi.

​The Office of HIV/AIDS Network Coordination (HANC) hosted a webinar featuring Dr. Carl Dieffenbach​, Director of the Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases; Dr. Sarah Read, Deputy Director of the DAIDS; Manizhe Payton, Director of the Office of Clinical Site Oversight (OCSO) at DAIDS; and Dr. Jeffrey Schouten, HANC Director, in an effort to inform network stakeholders and community about the impact of COVID-19 on HIV research.


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