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Trial record 1 of 1 for:    NCT04379271
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A Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator's Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19 (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04379271
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by (Responsible Party):
Immunic AG

Brief Summary:

At present there is no approved drug treatment for Covid-19. In this study we plan to investigate if an experimental drug called IMU-838 (vidofludimus calcium) can improve your symptoms, prevent worsening that would initiate further treatments such as ventilation, and can lower your virus number if given in addition to your doctor's choice of standard therapy. We will also test if IMU-838 has any side effects and measure the level of IMU 838 in your blood.

Experimental drug means that it is not yet authorized for marketing in your country. To date approximately 600 individuals have received IMU-838 (or a drug similar to IMU-838 that contains the same active substance as IMU-838) in research studies.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: IMU-838 Other: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind, placebo-controlled, randomized, parallel-group trial
Masking: Double (Participant, Investigator)
Masking Description:

Trial participants, the investigator and all other personnel directly involved in the conduct of the trial will be blinded to treatment assignments.

To maintain the blind, IMU-838 and placebo tablets will have identical appearance, shape and color, and will have identical labeling and packaging. To minimize the potential for bias, treatment randomization information will be kept confidential by the responsible personnel and will not be released to investigators, other trial center personnel, or the Sponsor's designee(s).

Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator's Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19
Actual Study Start Date : June 11, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IMU-838
twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC)
Drug: IMU-838

Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable).

If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube.

Other Name: vidofludimus calcium

Placebo Comparator: Placebo
twice-daily (BID) oral placebo (+ SoC)
Other: Placebo
Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838




Primary Outcome Measures :
  1. Proportion of patients without any need* for INV until end-of-study (EoS) [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Clinical


Secondary Outcome Measures :
  1. Duration of ICU treatment until EoS [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Key Secondary

  2. 28-day all-cause mortality [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Key Secondary

  3. Time to clinical improvement [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Efficacy: defined as the time from first dose of investigational medicinal product (IMP) to an improvement of at least 2 points on the WHO 9 category ordinal scale , or live discharge from hospital without oxygen supplementation, whichever comes first

  4. Duration of hospitalization [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Efficacy: Duration of hospitalization (for US sites only: or treatment in special outpatient setting in lieu of hospitalization due to resource restraints)

  5. Proportion of patients both for all patients and surviving patients free of renal-replacement therapy (RRT)* until EoS [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Efficacy

  6. Proportion of patients both for all patients and surviving patients free from extracorporeal membrane oxygenation (ECMO)* until EoS [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Efficacy

  7. Proportion of patients free of INV until Days 6 and 14* [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Efficacy

  8. Proportion of patients free of RRT until Days 6 and 14* [ Time Frame: Day 0 to Days 6 and 14 ]
    Efficacy

  9. Proportion of patients free ECMO until Days 6 and 14* [ Time Frame: Day 0 to Days 6 and 14 ]
    Efficacy

  10. Proportion of patients with improvement of at least 2 points (from randomization) on the 9-category WHO ordinal scale1 on Days 6, 14, and 28 [ Time Frame: on Days 6, 14, and 28 ]
    Efficacy

  11. Proportion of patients with auxiliary oxygen therapy (including all types of oxygen therapy) on Days 6, 14, and 28 [ Time Frame: on Days 6, 14, and 28 ]
    Efficacy

  12. Proportion of patients with clinical recovery: Axillary temperature ≤36.6 ℃, or oral temperature ≤37.2 ℃, or rectal or tympanic temperature ≤37.8 ℃; [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Efficacy

  13. Proportion of patients with clinical recovery: Respiratory frequency ≤24 times/min without oxygen inhalation; and [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Efficacy

  14. Proportion of patients with clinical recovery: Oxygen saturation ≥98% without oxygen inhalation [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Efficacy

  15. Proportion of patients with clinical improvement, defined as the time from first dose of IMP to an improvement of at least 2 points on the WHO 9 category ordinal scale, or live discharge from hospital without oxygen supplementation, whichever comes first [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Efficacy

  16. Clinical patient status on the 9-category WHO ordinal scale1 on Days 6, 14, and 28 [ Time Frame: on Days 6, 14, and 28 ]
    Efficacy

  17. Duration of INV [ Time Frame: Throughout the Study (Day 0 to Day 28 ) ]
    Efficacy

  18. Duration of ECMO [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  19. Duration of RRT [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  20. Duration of auxiliary oxygen therapy (including all types of oxygen therapy) [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  21. Duration of hospitalization for survivors [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  22. The rate of ICU* admission on Days 6, 14, and 28 [ Time Frame: on Days 6, 14, and 28 ]
    Efficacy

  23. Hospital-free days [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  24. Time from IMP treatment initiation to death [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  25. Time to first prescription of INV [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  26. Time to first prescription of RRT [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  27. Time to first prescription of ECMO [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  28. Time to first prescription of INV, RRT, and ECMO [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  29. Time to ICU admission [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  30. Cumulative dose of vasoactive therapies and days with vasoactive therapies (daily until Day 14) [ Time Frame: Day 0 to day 14 ]
    Efficacy

  31. Time to clinical recovery [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Efficacy

  32. Morning trough plasma levels of IMU-838 on Days 0, 1, 2, 3, 6, 14, and 28 [ Time Frame: on Days 0, 1, 2, 3, 6, 14, and 28 ]
    Pharmacokinetics

  33. Correlation of trough levels (quartiles) to selected clinical outcomes (Clinical improvement accoding to WHO criteria) [ Time Frame: on Days 0, 1, 2, 3, 6, 14, and 28 ]
    Pharmacokinetics

  34. Adverse events (AEs) and serious AEs [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Safety

  35. Vital signs: height [ Time Frame: only at Screening ]
    Safety Height in centimeters will be recorded without shoes. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.

  36. Vital signs: weight [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Safety Weight in kilograms will be recorded without shoes. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.

  37. Vital signs: body temperature (ºC) [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Safety Body temperature can be measured axillary, oral, rectal or tympanic, but should be always measured by the same method for a patient. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.

  38. Vital signs: pulse rates, [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Safety Pulse must be measured with the patient in a seated position (if possible), after at least 5 minutes at rest. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.

  39. Vital signs: systolic and diastolic blood pressures [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Safety Blood pressure (systolic and diastolic) must be measured with the patient in a seated position (if possible), after at least 5 minutes at rest. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE.

  40. Clinical laboratory parameters: blood chemistry [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Safety

  41. Clinical laboratory parameters: hematology [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Safety

  42. Clinical laboratory parameters: urinalysis [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Safety

  43. 12-lead electrocardiogram: heart rate [ Time Frame: Day 0 to Day 6 and Day 28 ]
    Safety

  44. 12-lead electrocardiogram: PQ-interval [ Time Frame: Day 0 to Day 6 and Day 28 ]
    Safety

  45. 12-lead electrocardiogram: QRS-interval [ Time Frame: Day 0 to Day 6 and Day 28 ]
    Safety

  46. 12-lead electrocardiogram: QT interval [ Time Frame: Day 0 to Day 6 and Day 28 ]
    Safety

  47. 12-lead electrocardiogram: the heart rate-corrected QTc interval (according to Bazett's formula) [ Time Frame: Day 0 to Day 6 and Day 28 ]
    Safety

  48. Temperature [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Safety

  49. D-dimer [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Disease markers

  50. Lactate dehydrogenase (LDH) [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Disease markers

  51. C-reactive protein [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Disease markers

  52. Troponin I [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Disease markers

  53. Procalcitonin [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Disease markers

  54. Correlation of disease markers to selected clinical outcomes (Clinical improvement accoding to WHO criteria) [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Disease markers

  55. Severe Acute Respiratory Syndrome Coronavirus Virus (SARS-CoV-2) mean viral load - log10 copies in spontaneous sputum and nasopharyngeal swab samples: Decrease of SARS-CoV-2 viral load [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Virologic markers

  56. Severe Acute Respiratory Syndrome Coronavirus Virus (SARS-CoV-2) mean viral load - log10 copies in spontaneous sputum and nasopharyngeal swab samples: Time course of SARS-CoV-2 viral load [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Virologic markers

  57. Qualitative virologic clearance in spontaneous sputum and nasopharyngeal swab samples (= 2 consecutive negative SARS-CoV-2 reverse transcriptase polymerase chain reaction tests at least 24 hours apart) [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Virologic markers

  58. Rate of conversion to a negative SARS-CoV-2 (qualitative) test on Days 6, 14 and 28 [ Time Frame: on Days 6, 14 and 28 ]
    Virologic markers

  59. Time to conversion to a negative SARS-CoV-2 (qualitative) test [ Time Frame: Throughout the Study (Day 0 to Day 28) ]
    Virologic markers

  60. Interleukin (IL)-17 [ Time Frame: Day 0, 6, 14 and Day 28 ]
    Biomarkers

  61. Interleukin (IL)-1ß [ Time Frame: Day 0, 6, 14 and Day 28 ]
    Biomarkers

  62. Interleukin (IL)-6 [ Time Frame: Day 0, 6, 14 and 28 ]
    Biomarkers

  63. interferon gamma (IFNγ) [ Time Frame: Day 0, 6, 14 and 28 ]
    Biomarkers

  64. tumor necrosis factor alpha [ Time Frame: Day 0, 6, 14 and 28 ]
    Biomarkers

  65. Immunoglobulin (Ig)A and IgG antibodies against SARS-CoV-2: • Time to appearance of IgA and/or IgG antibodies [ Time Frame: Day 0, 6, 14 and 28 ]
    Serologic markers

  66. Immunoglobulin (Ig)A and IgG antibodies against SARS-CoV-2: • Proportion of patients with IgA and/or IgG antibodies on Days 6, 14, and 28 [ Time Frame: Day 0, 6, 14 and 28 ]
    Serologic markers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients at least 18 years old (may be extended to include also children 12 years or older after the 1st interim analysis)
  2. Admitted to the hospital or other medical in-patient treatment facility for treatment of COVID-19 The hospitalization needs to be for medical reasons (treatment of COVID-19 disease) and cannot be for social reasons or due to housing insecurity.

    For US sites only: If the investigator would commonly hospitalize the patient but for healthcare resource reasons decides to treat the patient in a specially designed out-patient setting, then such patients are also allowed to enter the trial (please note that in this case the patient would be counted as clinical status category 3). The investigator then must assure that the patient has at least a twice daily assessment by qualified trial personnel and all laboratory assessments can be adequately performed as per protocol. The Sponsor reserves the right to discontinue this option via administrative letter if such assurances cannot be met by any site.

  3. SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) test in a nasopharyngeal, oropharyngeal or respiratory sample at ≤4 days before randomization
  4. Moderate COVID-19 disease defined as fulfilling clinical status category 3 or 4 on the WHO 9-point ordinal scale [21]:

    • Category 3: Hospitalized (see note above for US only), virus-positive, no oxygen therapy with the following conditions:
    • The hospitalization needs to be for medical reasons (treatment of COVID-19 disease) and cannot be for social reasons or due to housing insecurity
    • Category 4: Hospitalized, virus-positive, oxygen by mask or nasal prongs (excluding high-flow oxygen therapy) with the following conditions:
    • Peripheral capillary oxyhemoglobin saturation (SpO2) >92% at maximum of 6 liters oxygen flow per minute
    • Stable respiratory rate ≤30 breaths/min at maximum of 6 liters oxygen flow per minute
  5. Presence of at least 1 symptom characteristic for COVID-19 disease i.e., fever, cough or respiratory distress
  6. Willingness and ability to comply with the protocol
  7. Written informed consent given prior to any trial-related procedure
  8. For women of childbearing potential: Application of a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly) together with a barrier method between trial consent and 30 days after the last intake of the IMP.

    Highly effective forms of birth control are those with a failure rate less than 1% per year and include:

    • oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation
    • oral, injectable, or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation
    • intrauterine device or intrauterine hormone-releasing system
    • bilateral tubal occlusion
    • vasectomized partner (i.e., the patient's male partner underwent effective surgical sterilization before the female patient entered the clinical trial and is the sole sexual partner of the female patient during the clinical trial)
    • sexual abstinence (acceptable only if it is the patient's usual form of birth control/lifestyle choice; periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are no acceptable methods of contraception)

    Barrier methods of contraception include:

    • Condom
    • Occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository
  9. Male patients must agree not to father a child or to donate sperm starting at Screening, throughout the clinical trial and for 30 days after the last intake of the IMP. Male patients must also

    • abstain from sexual intercourse with a female partner (acceptable only if it is the patient's usual form of birth control/lifestyle choice), or
    • use adequate barrier contraception during treatment with the IMP and until at least 30 days after the last intake of the IMP, and
    • if they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method as outlined in inclusion criterion 8
    • if they have a pregnant partner, they must use condoms while taking the IMP to avoid exposure of the fetus to the IMP

Exclusion Criteria:

Underlying disease-related exclusion criteria

  1. Involvement in the trial is not in the patient's best interest according to the investigator's decision, including the presence of any condition that would, in the assessment of the investigator, not allow the protocol to be followed safely Note: The investigator should particularly consider exclusion of patients at increased risk for serious or fatal AEs in case of worsening of the pulmonary perfusion. This includes, but is not limited to, pre-existing pulmonary hypertension, severe chronic respiratory disease, severely increased risk for thromboembolic complications and moderate to severe left ventricular ejection fraction (LVEF) dysfunction. In addition, other known risk factors of highest risk of mortality in COVID-19 patients should be considered.
  2. Presence of respiratory failure, shock, and/or combined failure of other organs that requires ICU monitoring in the near foreseeable future
  3. Critical patients whose expected survival time <48-72 hours
  4. Presence of the following laboratory values at screening:

    • White blood cell count (WBC) <1.0 x 109/L
    • Platelet count <100,000/mm³ (<100 x 109/L)
    • Total bilirubin>2 x ULN
    • Alanine aminotransferase (ALT) or gamma glutamyl transferase (GGT) >5 x ULN
  5. Participation in any other interventional clinical trial
  6. Hospitalization primarily for other reasons than COVID-19 (including primarily for concomitant conditions during ongoing SARS-CoV-2 infection)
  7. Anticipated transport to a different hospital or institution, in particular when such transport is anticipated for pending ECMO or RRT treatment
  8. Clinical suspicion of a bacterial superinfection at Screening IMP-related exclusion criteria
  9. Patients who cannot take drugs orally
  10. Allergic or hypersensitive to the IMP or any of the ingredients
  11. Use of the following concomitant medications is prohibited from Screening to end of treatment with IMP in this trial (up to Day 14) if not indicated otherwise in this protocol:

    • Concurrent use of any mycophenolate mofetil or of methotrexate exceeding 17.5 mg weekly
    • Any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad (Zurampic™) as well as uricosuric drugs such as probenecid
    • Current treatments for any malignancy, in particular irinotecan, paclitaxel, tretinoin, bosutinib, sorafenib, enasidenib, erlotinib, regorafenib, pazopanib and nilotinib
    • Any drug significantly restricting water diuresis, in particular vasopressin and vasopressin analogs
    • Use of rosuvastatin at daily doses higher than 10 mg
    • Arbidol and Colchicine
    • Any use of other DHODH inhibitors, including teriflunomide (Aubagio™) or leflunomide (Arava™)
    • Chloroquine and Hydroxychloroquine during the entire trial unless taken for indicated use before entering the trial
  12. Use of any investigational product within 8 weeks or 5x the respective half-life before the date of informed consent, whichever is longer, and throughout the duration of the trial General exclusion criteria
  13. Patients who have a "do not intubate" or "do not resuscitate" order (unless the patient waives in writing this order and will allow intubation for the duration of the trial period)
  14. Patients with end-stage liver disease (Child Pugh C score)
  15. History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (New York Heart Association [NYHA] class 3 or 4) Note: NYHA class 3: Cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. NYHA class 4: Cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
  16. Legal incapacity, limited legal capacity, or any other condition that makes the patient unable to provide consent for the trial
  17. Pregnant or breastfeeding
  18. An employee of an investigator or Sponsor or an immediate relative of an investigator or Sponsor
  19. Patients institutionalized due to judicial order

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379271


Contacts
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Contact: Andreas Muehler, Dr. +49 89 2500 794 64 andreas.muehler@imux.com
Contact: Neera Ahuja, Prof. +1 650 497-7304 nkahuja@stanford.edu

Locations
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Bulgaria
Military Medical Academy, Clinic of Infectious Diseases Recruiting
Sofia, Bulgaria, 1606
Contact: Andreas Muehler, Dr.       andreas.muehler@imux.com   
UMHATEM N.I.Pirogov, Clinic of internal diseases Recruiting
Sofia, Bulgaria, 1606
Contact: Andreas Muehler, Dr.       andreas.muehler@imux.com   
Germany
University Hospital Frankfurt, Infectious Diseases Recruiting
Frankfurt, Germany, 60590
Contact: Andreas Muehler, Dr.       andreas.muehler@imux.com   
Clinic of the Hannover Medical School, Pneumology Clinic Recruiting
Hannover, Germany, 30625
Contact: Andreas Muehler, Dr.       andreas.muehler@imux.com   
Sponsors and Collaborators
Immunic AG
FGK Clinical Research GmbH
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Responsible Party: Immunic AG
ClinicalTrials.gov Identifier: NCT04379271    
Other Study ID Numbers: P2-IMU-838-COV
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs