Coronavirus InfectionNCT04380870
Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19
An observational study of Coronavirus Infection, run by Center for Integrated Care at 1 site in United States.
Trial summary
The purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 114 years
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Chinese Herbal Medicine
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2020to 11 May 2025
- Phase
- Observational
- 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 18 to 114 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample.
Who may be able to join
- Eighteen year of age.
- Experienced one or more of the following symptoms in the last 28 days: cough, fever, shortness of breath, diarrhea, nausea, or abdominal pain OR am at high risk of exposure.
- Have a Primary Care Provider.
Who cannot join
- Breastfeeding, pregnant, or expect that I might be pregnant.
- Ineligible to receive a telehealth consult for any reason.
- Unable to communicate in English verbally, and in writing.
- Have an open legal case about my health.
- Taking anticoagulants, immunosuppressants, antiseizure medications, antipsychotic medications or am in active cancer treatment
- Taking medications with some risk of interaction with the herbal medicine. This will be determined at the time of the herbal consult by the clinic team.
- Discretion of the practitioner or screener.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Intstitute of East Asian Medicine
Seattle, Washington, 98108
Katherine Taromina, DACM, 206-517-4541, ktaromina@sieam.edu
Katherine Taromina, DACM
About this study
Official title: Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19: A Descriptive, Longitudinal, Pragmatic Cohort Study
The purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19.
Read the detailed description
The purpose of this study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19 infection who participate in Chinese herbal medicine (CHM) telehealth visits and take CHM. CHM includes over 400 medicinal substances and CHM formulas are individualized at each visit according to the patient's presentation. CHM has been used to treat cough, shortness of breath, and fatigue and mechanisms of action have been investigated for SARS and H1N1 influenza prevention and treatment by anti-inflammatory effects and antiviral activity. Yet, there is a gap in our understanding of the clinical application of CHM in a community sample of individuals experiencing symptoms that may be related to COVID-19. The investigators have no pragmatic clinic data about the use of CHM for coronaviruses.
Safe and effective treatment of symptoms associated with COVID-19 is a top international priority and research is needed to better understand if CHM is a safe intervention to treat symptoms. Further, dissemination of trustworthy CHM treatment approaches for this complex and emergent condition is needed within the CHM and scientific communities.
Aim 1: Conduct quantitative analyses of the collected data and disseminate findings to CHM clinicians and to the scientific community.
Case series will be reported bi-weekly to CHM clinicians via the SIEAM website including exposure, comorbidities, symptom change, concurrent medications, CHM prescriptions, adverse events and usability. Data will be analyzed at the study conclusion for presentation to the scientific community.
Aim 2: Conduct qualitative analyses of the collected data and disseminate findings to CHM clinicians and to the scientific community.
Chart notes reflecting clinicians' clinical reasoning will be content analyzed and posted bi-weekly on the SIEAM website. This will provide timely information for the CHM clinical community from highly experienced clinicians. Data will be analyzed at the study conclusion for presentation to the scientific community.
- Conditions
- Coronavirus Infection
- Being tested
- Chinese Herbal Medicine
- Keywords
- COVID-19 symptoms, Chinese Herbal Medicine, Cough, Shortness of Breath, Fatigue, Epidemic, Infectious Disease, Dyspnea, Diarrhea, Myalgia, Nausea, Fever, Pneumonia
- Medical subject headings
- Coronavirus Infections, Cough, Dyspnea, Fatigue, Communicable Diseases, Diarrhea, Myalgia, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herbal MedicineDietary supplement
Chinese Herbal Medicine (CHM) has been used in the prevention and treatment of epidemic diseases dating back to the Han, Ming and Qing Dynasties and extending al the way through modern times. CHM formulas may contain plant elements of root, seed, back, stem or leaf in addition to minerals and other natural substances. All herbs dispensed in this trial will be from Spring Wind Herb Company.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Herbal Medicine | Chinese Herbal Medicine for suspected COVID-19 symptoms. Receives: Dietary Supplement: Chinese Herbal Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported main complaint
Patient reported change
Measured: 24 hours
Patient reported main complaint
Patient reported change
Measured: 48 hours
Patient reported main complaint
Patient reported change
Measured: 3 months
Patient reported main complaint
Patient reported change
Measured: 12 months
Secondary outcomes (4)
Conduct qualitative analyses of data
Patient interview notes as written by clinicians.
Measured: 24 hours
Conduct qualitative analyses of data
Patient interview notes as written by clinicians.
Measured: 48 hours
Conduct qualitative analyses of data
Patient interview notes as written by clinicians.
Measured: 3 months
Conduct qualitative analyses of data
Patient interview notes as written by clinicians.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start11 May 2020
- Primary completion11 Dec 2021 (estimated)
- Study completion11 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Integrated Care
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, University of California, San Francisco
- Responsible party
- Principal investigator, Katherine Taromina, Center for Integrated Care
- Investigators
- Lisa Taylor-Swanson, PhD, Principal investigator, University of UtahLisa Conboy, DSc, Principal investigator, Beth Israel Deaconness Medical Center, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380870
- Sponsor's protocol ID
- 01-04-20
- Status last verified
- Sep 2021
- First submitted
- 5 May 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Confidential, de-identified,demographic and health symptoms will be collected as part of this study.
Publications
Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
PubMed 32015507Wong SH, Lui RN, Sung JJ. Covid-19 and the digestive system. J Gastroenterol Hepatol. 2020 May;35(5):744-748. doi: 10.1111/jgh.15047. Epub 2020 Apr 19.
PubMed 32215956Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
PubMed 32182409Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.
PubMed 32179124Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570Yuen KS, Ye ZW, Fung SY, Chan CP, Jin DY. SARS-CoV-2 and COVID-19: The most important research questions. Cell Biosci. 2020 Mar 16;10:40. doi: 10.1186/s13578-020-00404-4. eCollection 2020.
PubMed 32190290Poston JT, Patel BK, Davis AM. Management of Critically Ill Adults With COVID-19. JAMA. 2020 May 12;323(18):1839-1841. doi: 10.1001/jama.2020.4914. No abstract available.
PubMed 32215647Sheahan TP, Sims AC, Graham RL, Menachery VD, Gralinski LE, Case JB, Leist SR, Pyrc K, Feng JY, Trantcheva I, Bannister R, Park Y, Babusis D, Clarke MO, Mackman RL, Spahn JE, Palmiotti CA, Siegel D, Ray AS, Cihlar T, Jordan R, Denison MR, Baric RS. Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses. Sci Transl Med. 2017 Jun 28;9(396):eaal3653. doi: 10.1126/scitranslmed.aal3653.
PubMed 28659436Colson P, Rolain JM, Raoult D. Chloroquine for the 2019 novel coronavirus SARS-CoV-2. Int J Antimicrob Agents. 2020 Mar;55(3):105923. doi: 10.1016/j.ijantimicag.2020.105923. Epub 2020 Feb 15. No abstract available.
PubMed 32070753Lai CC, Liu YH, Wang CY, Wang YH, Hsueh SC, Yen MY, Ko WC, Hsueh PR. Asymptomatic carrier state, acute respiratory disease, and pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): Facts and myths. J Microbiol Immunol Infect. 2020 Jun;53(3):404-412. doi: 10.1016/j.jmii.2020.02.012. Epub 2020 Mar 4.
PubMed 32173241Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4. No abstract available.
PubMed 32020029Yao X, Ye F, Zhang M, Cui C, Huang B, Niu P, Liu X, Zhao L, Dong E, Song C, Zhan S, Lu R, Li H, Tan W, Liu D. In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Jul 28;71(15):732-739. doi: 10.1093/cid/ciaa237.
PubMed 32150618Chu CM, Cheng VC, Hung IF, Wong MM, Chan KH, Chan KS, Kao RY, Poon LL, Wong CL, Guan Y, Peiris JS, Yuen KY; HKU/UCH SARS Study Group. Role of lopinavir/ritonavir in the treatment of SARS: initial virological and clinical findings. Thorax. 2004 Mar;59(3):252-6. doi: 10.1136/thorax.2003.012658.
PubMed 14985565
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describing Chinese Herbal Medicine Telehealth Care for Symptoms Related to Infectious Diseases Such as COVID-19: A Descriptive, Longitudinal, Pragmatic Cohort Study
- ClinicalTrials.gov ID
- NCT04380870
- Acronym / sponsor ID
- 01-04-20
- Conditions
- Coronavirus Infection
- Keywords
- COVID-19 symptoms, Chinese Herbal Medicine, Cough, Shortness of Breath, Fatigue, Epidemic, Infectious Disease, Dyspnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Center for Integrated CareUniversity, hospital or other
- Collaborators
- University of Utah, University of California, San Francisco
- Study start
- 11 May 2020 (actual)
- Primary completion
- 11 Dec 2021 (estimated)
- Study completion
- 11 May 2025 (estimated)
- First posted
- 8 May 2020 (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.
The purpose of the study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19.
Detailed description
The purpose of this study is to design and execute a prospective, longitudinal, descriptive cohort study in a pragmatic clinical practice for adults with symptoms that may be related to COVID-19 infection who participate in Chinese herbal medicine (CHM) telehealth visits and take CHM. CHM includes over 400 medicinal substances and CHM formulas are individualized at each visit according to the patient's presentation. CHM has been used to treat cough, shortness of breath, and fatigue and mechanisms of action have been investigated for SARS and H1N1 influenza prevention and treatment by anti-inflammatory effects and antiviral activity. Yet, there is a gap in our understanding of the clinical application of CHM in a community sample of individuals experiencing symptoms that may be related to COVID-19. The investigators have no pragmatic clinic data about the use of CHM for coronaviruses.
Safe and effective treatment of symptoms associated with COVID-19 is a top international priority and research is needed to better understand if CHM is a safe intervention to treat symptoms. Further, dissemination of trustworthy CHM treatment approaches for this complex and emergent condition is needed within the CHM and scientific communities.
Aim 1: Conduct quantitative analyses of the collected data and disseminate findings to CHM clinicians and to the scientific community.
Case series will be reported bi-weekly to CHM clinicians via the SIEAM website including exposure, comorbidities, symptom change, concurrent medications, CHM prescriptions, adverse events and usability. Data will be analyzed at the study conclusion for presentation to the scientific community.
Aim 2: Conduct qualitative analyses of the collected data and disseminate findings to CHM clinicians and to the scientific community.
Chart notes reflecting clinicians' clinical reasoning will be content analyzed and posted bi-weekly on the SIEAM website. This will provide timely information for the CHM clinical community from highly experienced clinicians. Data will be analyzed at the study conclusion for presentation to the scientific community.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese Herbal Medicine | – | Dietary Supplement: Chinese Herbal MedicineChinese Herbal Medicine for suspected COVID-19 symptoms. |
Who may qualify
- Ages
- 18 to 114 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample.
Key inclusion criteria (3 listed)
- Eighteen year of age.
- Experienced one or more of the following symptoms in the last 28 days: cough, fever, shortness of breath, diarrhea, nausea, or abdominal pain OR am at high risk of exposure.
- Have a Primary Care Provider.
Key exclusion criteria (7 listed)
- Breastfeeding, pregnant, or expect that I might be pregnant.
- Ineligible to receive a telehealth consult for any reason.
- Unable to communicate in English verbally, and in writing.
- Have an open legal case about my health.
- Taking anticoagulants, immunosuppressants, antiseizure medications, antipsychotic medications or am in active cancer treatment
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 |
|---|---|---|
| Chinese Herbal MedicineChinese Herbal Medicine (CHM) has been used in the prevention and treatment of epidemic diseases dating back to the Han, Ming and Qing Dynasties and extending al the way through modern times. CHM formulas may contain plant elements of root, seed, back, stem or leaf in addition to minerals and other natural substances. All herbs dispensed in this trial will be from Spring Wind Herb Company. | Dietary supplement | Chinese Herbal Medicine |
Primary outcome
Patient reported main complaint
Time frame: 24 hours
Patient reported change
Patient reported main complaint
Time frame: 48 hours
Patient reported change
Patient reported main complaint
Time frame: 3 months
Patient reported change
Patient reported main complaint
Time frame: 12 months
Patient reported change
4 secondary outcomes
Conduct qualitative analyses of data
Time frame: 24 hours
Conduct qualitative analyses of data
Time frame: 48 hours
Conduct qualitative analyses of data
Time frame: 3 months
Conduct qualitative analyses of data
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Background: PubMed 32015507Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
- Background: PubMed 32215956Wong SH, Lui RN, Sung JJ. Covid-19 and the digestive system. J Gastroenterol Hepatol. 2020 May;35(5):744-748. doi: 10.1111/jgh.15047. Epub 2020 Apr 19.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 32182409van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO, de Wit E, Munster VJ. Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1. N Engl J Med. 2020 Apr 16;382(16):1564-1567. doi: 10.1056/NEJMc2004973. Epub 2020 Mar 17. No abstract available.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32179124Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Background: PubMed 32190290Yuen KS, Ye ZW, Fung SY, Chan CP, Jin DY. SARS-CoV-2 and COVID-19: The most important research questions. Cell Biosci. 2020 Mar 16;10:40. doi: 10.1186/s13578-020-00404-4. eCollection 2020.
- Background: PubMed 32215647Poston JT, Patel BK, Davis AM. Management of Critically Ill Adults With COVID-19. JAMA. 2020 May 12;323(18):1839-1841. doi: 10.1001/jama.2020.4914. No abstract available.
- Background: PubMed 28659436Sheahan TP, Sims AC, Graham RL, Menachery VD, Gralinski LE, Case JB, Leist SR, Pyrc K, Feng JY, Trantcheva I, Bannister R, Park Y, Babusis D, Clarke MO, Mackman RL, Spahn JE, Palmiotti CA, Siegel D, Ray AS, Cihlar T, Jordan R, Denison MR, Baric RS. Broad-spectrum antiviral GS-5734 inhibits both epidemic and zoonotic coronaviruses. Sci Transl Med. 2017 Jun 28;9(396):eaal3653. doi: 10.1126/scitranslmed.aal3653.
- Background: PubMed 32070753Colson P, Rolain JM, Raoult D. Chloroquine for the 2019 novel coronavirus SARS-CoV-2. Int J Antimicrob Agents. 2020 Mar;55(3):105923. doi: 10.1016/j.ijantimicag.2020.105923. Epub 2020 Feb 15. No abstract available.
- Background: PubMed 32173241Lai CC, Liu YH, Wang CY, Wang YH, Hsueh SC, Yen MY, Ko WC, Hsueh PR. Asymptomatic carrier state, acute respiratory disease, and pneumonia due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): Facts and myths. J Microbiol Immunol Infect. 2020 Jun;53(3):404-412. doi: 10.1016/j.jmii.2020.02.012. Epub 2020 Mar 4.
- WHO Coronavirus disease (COVID-19) situation dashboardLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Confidential, de-identified,demographic and health symptoms will be collected as part of this study.
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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.
Lisa Taylor-Swanson, PhD principal investigator
University of Utah
Lisa Conboy, DSc principal investigator
Beth Israel Deaconness Medical Center, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection, run by Center for Integrated Care at 1 site in United States.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Sep 2021. 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 United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa A Taylor-Swanson, PhD (801-585-5486, lisa.taylor-swanson@nurs.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported main complaint (time frame: 24 hours). The study lists 4 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 NCT04380870, which also lists 30 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 28 Sep 2021.