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CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


AzithromycinWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (65)


Name (Synonyms) Correlation
drug505 Hydroxychloroquine Wiki 0.39
drug1040 SivoMixx (200 billion) Wiki 0.27
drug1258 Zinc Sulfate Wiki 0.27
drug1314 hydroxychloroquine Wiki 0.22
drug590 Interferon-Beta Wiki 0.19
drug1202 Ultra-Low-dose radiotherapy Wiki 0.19
drug1204 Umbilical Cord Mesenchymal Stem Cells Wiki 0.19
drug1119 TD-0903 Wiki 0.19
drug849 Piperacillin/tazobactam Wiki 0.19
drug966 Rifampin Wiki 0.19
drug445 Folic Acid Wiki 0.19
drug1401 standard procedure Wiki 0.19
drug101 Aviptadil (VIP) Wiki 0.19
drug470 HCQ & AZ vs HCQ+SIR Wiki 0.19
drug334 Cytokine Adsorption Wiki 0.19
drug195 CAStem Wiki 0.19
drug502 Hydoxychloroquine or Chloroquine Wiki 0.19
drug654 Low molecular weight heparin Wiki 0.19
drug385 ECCO2R Wiki 0.19
drug9 1: ILT101 Wiki 0.19
drug1069 Standard of care management Wiki 0.19
drug812 PEEP trial Wiki 0.19
drug1420 ventilatory support with oxygen therapy Wiki 0.19
drug252 Cell therapy protocol 2 Wiki 0.19
drug455 Gargle/Mouthwash Wiki 0.19
drug1290 consultation Wiki 0.19
drug1302 eculizumab Wiki 0.19
drug808 Oxygen-ozone therapy, probiotic supplementation and Standard of care Wiki 0.19
drug251 Cell therapy protocol 1 Wiki 0.19
drug327 Corticosteroid Wiki 0.19
drug737 Naltrexone Wiki 0.19
drug642 Lopinavir 200Mg/Ritonavir 50Mg Tab Wiki 0.19
drug638 Lopinavir / Ritonavir Pill Wiki 0.19
drug458 Gimsilumab Wiki 0.19
drug52 Alteplase 100 MG [Activase] Wiki 0.19
drug366 Dexmedetomidine Injectable Product Wiki 0.19
drug328 Corticosteroid injection Wiki 0.19
drug618 Ketamine Wiki 0.19
drug53 Alteplase 50 MG [Activase] Wiki 0.19
drug16 2: Placebo Comparator Wiki 0.19
drug379 Doxycycline Wiki 0.13
drug645 Lopinavir-Ritonavir Wiki 0.13
drug1135 Telmisartan Wiki 0.13
drug378 Dornase Alfa Inhalation Solution [Pulmozyme] Wiki 0.13
drug264 Chloroquine Sulfate Wiki 0.13
drug1168 Tocilizumab Wiki 0.13
drug431 Favipiravir Wiki 0.12
drug522 Hydroxychloroquine Sulfate Wiki 0.11
drug1062 Standard of Care Wiki 0.11
drug1255 Zinc Wiki 0.11
drug1082 Standard treatment Wiki 0.11
drug752 Nitazoxanide Wiki 0.11
drug850 Placebo Wiki 0.10
drug83 Ascorbic Acid Wiki 0.09
drug1231 Vitamin D Wiki 0.09
drug801 Oseltamivir Wiki 0.08
drug865 Placebo oral tablet Wiki 0.08
drug612 Ivermectin Wiki 0.08
drug1230 Vitamin C Wiki 0.08
drug1012 Sarilumab Wiki 0.08
drug262 Chloroquine Wiki 0.07
drug957 Remdesivir Wiki 0.06
drug647 Lopinavir/ritonavir Wiki 0.06
drug1067 Standard of care Wiki 0.06
drug872 Placebos Wiki 0.05

Correlated MeSH Terms (20)


Name (Synonyms) Correlation
D055371 Acute Lung Injury NIH 0.37
D012127 Respiratory Distress Syndrome, Newborn NIH 0.34
D012128 Respiratory Distress Syndrome, Adult NIH 0.31
D055370 Lung Injury NIH 0.24
D013577 Syndrome NIH 0.23
D003967 Diarrhea NIH 0.19
D000071257 Emergence Delirium NIH 0.19
D045169 Severe Acute Respiratory Syndrome NIH 0.14
D012598 Scoliosi NIH 0.13
D003693 Delirium NIH 0.13
D009103 Multiple Sclerosis NIH 0.13
D014947 Wounds and Injuries NIH 0.12
D011024 Pneumonia, Viral NIH 0.11
D018352 Coronavirus Infections NIH 0.11
D011014 Pneumonia NIH 0.08
D004417 Dyspnea NIH 0.08
D003141 Communicable Diseases NIH 0.06
D007249 Inflammation NIH 0.06
D007239 Infection NIH 0.05
D014777 Virus Diseases NIH 0.03

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0002014 Diarrhea HPO 0.19
HP:0002090 Pneumonia HPO 0.08
HP:0002098 Respiratory distress HPO 0.08

There are 28 clinical trials

Clinical Trials


1 Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis

Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central nervous system (CNS). The etiology of MS is unknown, although the immune system appears to play a role. Many different infectious agents have been proposed as potential causes for MS, including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS of MS patients. These findings have been replicated in part by other laboratories. The purpose of the current study is to test whether antibiotic treatment aimed at eradicating Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these criteria will be randomized to either placebo or antibiotic therapy, and followed for 6 months on treatment.

NCT00043264 Multiple Sclerosis Drug: Rifampin Drug: Azithromycin
MeSH:Pneumonia Multiple Sclerosis Sclerosis
HPO:Pneumonia


2 Proactive Prophylaxis With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19

This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.

NCT04322396 Virus Diseases Infection Viral Corona Virus Infection Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo oral tablet Drug: Placebo oral tablet
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Severe Acute Respiratory Syndrome Virus Diseases

Primary Outcomes

Measure: Number of days alive and discharged from hospital within 14 days

Time: 14 days

Secondary Outcomes

Description: The patient will becategorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".

Measure: Categorization of hospitalization status

Time: 14 days

Measure: Admitted to intensive care unit, if admitted to ICU then length of stay

Time: 14 days

Measure: Have used Non-invasive ventilation (NIV) during hospitalization

Time: 14 days

Measure: Mortality

Time: 30 days

Measure: Length of hospitalization

Time: 14 days

Measure: Days alive and discharged from hospital

Time: 30 days

Measure: Mortality

Time: 90 days

Measure: Mortality

Time: 365 days

Measure: Number of readmissions (all causes)

Time: 30 days

Measure: Number of days using non-invasive ventilation (NIV)

Time: 14 days

Description: Delta PaO2 measured in arterial puncture

Measure: Change in patient's oxygen partial pressure

Time: 4 days

Description: Delta PaCO2 measured in arterial puncture

Measure: Change in patient's carbondioxid partial pressure

Time: 4 days

Description: pH measured in arterial puncture

Measure: Level of pH in blood

Time: 4 days

Measure: Time for no oxygen supplement (or regular oxygen supplement "LTOT")

Time: 14 days

3 Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial

ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.

NCT04324463 Coronavirus Severe Acute Respiratory Syndrome Drug: Azithromycin Drug: Hydoxychloroquine or Chloroquine Drug: Interferon-Beta
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: In outpatients with COVID-19, the occurrence of hospital admission or death

Measure: Outpatients: Hospital Admission or Death

Time: Up to 6 weeks post randomization

Description: Patients intubated or requiring imminent intubation at the time of randomization will only be followed for the primary outcome of death.

Measure: Inpatients: Invasive mechanical ventilation or mortality

Time: Up to 6 weeks post randomization

4 Pilot, Randomized, Multicenter, Open-label Clinical Trial of Combined Use of Hydroxychloroquine, Azithromycin, and Tocilizumab for the Treatment of SARS-CoV-2 Infection (COVID-19)

COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality. Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.

NCT04332094 COVID-19 Drug: Tocilizumab Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Measure: In-hospital mortality

Time: Through hospitalization, an average of 2 weeks

Measure: Need for mechanical ventilation in the Intensive Care Unit

Time: Through hospitalization, an average of 2 weeks

5 Azithromycin for Prevention of Disease Progression in Patients With Mild or Moderate COVID-19

This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.

NCT04332107 COVID-19 SARS-CoV-2 Drug: Azithromycin Drug: Placebos

Primary Outcomes

Description: All-cause hospitalization or emergency room stay of >24 hours

Measure: Hospitalization

Time: 14 days

Secondary Outcomes

Description: Viral load by self-collected nasal swab

Measure: Viral load

Time: 3 days

Description: Viral load by self-collected saliva swab

Measure: Viral load

Time: 3 days

Description: All-cause mortality

Measure: Mortality

Time: 14 days

Description: Proportion of participants experiencing adverse events, including gastrointestinal side effects and rash

Measure: Adverse events

Time: 3 days

Description: Prevalence of positive SARS-CoV-2 test by self-collected nasal swab

Measure: Positive SARS-CoV-2 test - nasal swab

Time: 3 days

Description: Prevalence of positive SARS-CoV-2 test by self-collected saliva swab

Measure: Positive SARS-CoV-2 test - saliva swab

Time: 3 days

Description: Prevalence of positive SARS-CoV-2 test by self-collected rectal swab

Measure: Positive SARS-CoV-2 test - rectal swab

Time: 3 days

Description: Prevalence of genetic macrolide resistance determinants by self-collected rectal swab

Measure: Genetic macrolide resistance determinants

Time: 3 days

Description: Prevalence of cough, fever, myalgia, anosmia, shortness of breath, fatigue, conjunctivitis, and orthostatic symptoms

Measure: COVID-19 symptoms

Time: 3, 7, 14, 21 days

Description: Number of emergency room visits <24 hours

Measure: Number of emergency room visits

Time: 14 days

Description: Number of household members with confirmed or symptomatic COVID-19

Measure: Number of household members with COVID-19 (confirmed or symptomatic)

Time: 14 days

Description: Deaths within the study will be attempted to be matched with the US National Death Index

Measure: Death

Time: 21 days

6 Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial

This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating outpatients with suspected or confirmed COVID-19.

NCT04334382 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Description: Admitted to a hospital (not merely kept for emergency room observation)

Measure: Hospitalization within 14 days of enrollment

Time: From enrollment to 14 days after enrollment

Secondary Outcomes

Measure: Duration of COVID-19-attributable symptoms

Time: From enrollment to 14 days after enrollment

Description: Hospital-free days at 28 days (number of days patient not in hospital); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score

Measure: Hospital-free days at 28 days

Time: Admission (day 1) to 28 days after admission (day 28)

Description: Ventilator-free days at 28 days (number of days patient not on a ventilator); calculated as worst-rank ordinal with mortality by day 28 assigned the worst score

Measure: Ventilator-free days at 28 days

Time: Admission (day 1) to 28 days after admission (day 28)

Description: ICU-free days at 28 days, calculated as worst-rank ordinal with mortality by day 28 assigned the worst score

Measure: ICU-free days at 28 days

Time: Admission (day 1) to 28 days after admission (day 28)

7 A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).

NCT04334512 COVID-19 Corona Virus Infection Coronavirus-19 Sars-CoV2 Drug: Hydroxychloroquine Drug: Azithromycin Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Number of days from COVID-19 diagnosis to recovery via RT-PCR

Measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy

Time: 12 weeks

Description: Reduction and/or progression of symptomatic days, reduction of symptom severity

Measure: Reduction or Progression of Symptomatic Days

Time: 12 weeks

Description: Assess the symptom response to study therapy as measured by the survey in the EDC

Measure: Assess the safety of Quintuple Therapy

Time: 12 weeks

Description: Pulse from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via pulse

Time: 12 weeks

Description: Oxygen saturation from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via oxygen saturation

Time: 12 weeks

Description: EKG response from baseline to 12 weeks

Measure: Assess the safety of Quintuple Therapy via EKG

Time: 12 weeks

Description: Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy

Measure: Assess Tolerability of Quintuple Therapy

Time: 12 weeks

8 Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin

NCT04335552 SARS-CoV-2 Other: Standard of care Drug: Hydroxychloroquine Drug: Azithromycin
MeSH:Infection

Primary Outcomes

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: World Health Organization (WHO) ordinal scale measured at 14 days after enrollment

Time: Day 14

Secondary Outcomes

Measure: Rates of death during the index hospitalization

Time: Index hospitalization, up to 46 days

Measure: Number of days on mechanical ventilation for patients who were on mechanical ventilation at baseline

Time: Baseline

Measure: Proportion of patients not receiving mechanical ventilation at baseline who progress to requiring mechanical ventilation during the index hospitalization

Time: Index hospitalization, up to 46 days

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: WHO ordinal scale measured at 28 days after enrollment

Time: Day 28

Measure: Hospital length of stay in days for the index hospitalization

Time: Index hospitalization, up to 46 days

Measure: Rates of all-cause study medication discontinuation

Time: Index hospitalization, up to 46 days

Measure: Rates of severe adverse events

Time: Day 14

9 Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment

To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).

NCT04338698 COVID 19 Drug: Hydroxychloroquine Drug: Oseltamivir Drug: Azithromycin

Primary Outcomes

Description: The laboratory-based primary outcome will be turning test negative for COVID-19 on RT-qPCR calculated as viral load of < 150 i.u

Measure: Laboratory Result

Time: Day 07 on follow-up

Description: The clinical primary outcome will be improvement of two points on a seven-category ordinal scale shown below: Not hospitalized, able to resume normal activities Not hospitalized, but unable to resume normal activities Hospitalization, not requiring supplemental oxygen Hospitalization, requiring supplemental oxygen Hospitalization, requiring noninvasive mechanical ventilation Hospitalization, requiring invasive mechanical ventilation Death

Measure: Clinical Outcome

Time: Day 07 on follow-up

10 Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care Due to Coronavirus Disease 2019 (COVID-19)- Randomised Controlled Trial

Trial design: Prospective, multi-centre, randomised, pragmatic, double blind trial Methods: Participants: Adult (>18 years) within 24 hours of admission to intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria: symptoms of febrile disease for ≥1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, incl. long QT syndromes, participation in another outcome-based interventional trial within last 30 days, patients taking Hydrochloroquine for other indication than COVID-19, pregnancy. Interventions: Patients will be randomised in 1:1:1 ratio to receive Hydrochloroquine 800mg orally in two doses followed by 400mg daily in two doses and Azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or Hydrochloroquine+ placebo (HC group) or placebo + placebo (C-group) in addition to best standard of care, which may evolve during the trial period but will not differ between groups. Objective: To test the hypothesis that early administration of combination therapy slows disease progression and improves mechanical-ventilation free survival. Outcomes: Primary outcome: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14. Secondary outcomes: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline. ICU-LOS D28 and D 90 mortality (in hospital) Tertiary (exploratory) outcomes: Viral load at D7 of study enrolment (No of viral RNA copies/ml of blood), proportion of patients alive and rtPCR negative from nasal swab at D14, Difference of FiO2 requirement and respiratory system compliance between day 0 and 7. Randomization: In 1:1:1 ratio and stratified according to study centre and patients age (cut-off 70 years) Blinding (masking): Patients, treating clinicians, outcome assessors and data analyst will be blinded to study treatment allocation. Unblinded study pharmacist or research nurse will prepare investigational products.

NCT04339816 COVID-19 Respiratory Failure Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14.

Measure: Proportion of alive patients free off mechanical ventilation

Time: 14 days after enrolment

Secondary Outcomes

Description: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline.

Measure: Proportion of patients who avoided the need of mechanical ventilation

Time: 14 days

Description: Length of stay in intensive care unit

Measure: ICU LOS

Time: 28 days

Description: Proportion of patients who died by day 28

Measure: Mortality28

Time: 28 days

Description: Proportion of patients who died by day 90

Measure: Mortality90

Time: 90 days

11 COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients

To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A). To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).

NCT04341207 Cancer Cancer & Cancer & COVID 19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Measure: Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients

Time: Up to 3 months

Measure: Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin

Time: Up to 12 months

12 WU 352: Open-label, Randomized Controlled Trial of Hydroxychloroquine Alone or Hydroxychloroquine Plus Azithromycin or Chloroquine Alone or Chloroquine Plus Azithromycin in the Treatment of SARS CoV-2 Infection

This Phase III trial four treatment strategies non-critically ill hospitalized participants (not requiring ICU admission and/or mechanical ventilation) with SARS CoV-2 infection, Participants will receive hydroxychloroquine or chloroquine with or without azithromycin.

NCT04341727 Coronavirus Infection Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Chloroquine Sulfate
MeSH:Infection Communicable Diseases Coro Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time (hours) from randomization to recovery defined as 1) absence of fever, as defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications AND 2) absence of symptoms of greater than mild severity for 24 hours AND 3) not requiring supplemental oxygen beyond pre-COVID baseline AND 4) freedom from mechanical ventilation or death

Measure: Hours to recovery

Time: 42 days

Secondary Outcomes

Description: Time to resolution of fever defined as at least 48 hours since last temperature ≥ 38.0°C without the use of fever-reducing medications

Measure: Time fever resolution

Time: 42 days

13 Efficacy of Sarilumab + Azithromycin + Hydroxychloroquine, and Sarilumab Alone, for Adult Patients Hospitalized With Moderate to Severe COVID-19: a Multicenter Open-label 1:1 Randomized Controlled Trial

The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with moderate, severe pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering investigational treatments administration to patients enrolled in the CORIMUNO-19 cohort (NCT04324047). Sarilumab+Azithromycin+Hydroxychloroquine, or Sarilumab only will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation. All patients will receive standard of care along with randomized investigational treatments. Outcomes of included patients will be compared between groups as well as with outcomes of patients in the CORIMUNO-19 cohort treated with other immune modulators or standard of care.

NCT04341870 COVID19 SARS-CoV-2 Infection Drug: Sarilumab Drug: Azithromycin Drug: Hydroxychloroquine

Primary Outcomes

Description: Events considered are: need for ventilation (including invasive and non invasive ventilation), transfer to the Intensive Care Unit, death or new do-not-resuscitate (DNR) decision in the absence ventilation and outside ICU.

Measure: Need for ventilation (including invasive and non invasive ventilation), intensive care or death

Time: 14 days

Secondary Outcomes

Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: Early improvement: OMS progression scale <= 5

Time: 4 days

Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10

Measure: OMS progression scale

Time: 4, 7 and 14 days

Description: Overall survival

Measure: Survival

Time: 14, 28 and 90 days

Description: Number of ICU-free days alive

Measure: ICU-free days alive

Time: 14, 28 and 90 days

Description: Number of ventilation(invasive or non invasive)-free days alive

Measure: Ventilation-free days alive

Time: 14 and 28 days

Description: Number of hospital-free days alive

Measure: Hospital-free days alive

Time: 14, 28 and 90 days

Description: Number of oxygen therapy-free days alive

Measure: Oxygen therapy-free days alive

Time: 14 and 28 days

Description: SARS-CoV-2 viral load measurement by rtPCR

Measure: Time to negative viral excretion

Time: 90 days

Description: Immunophenotyping and multiplex cytokines (blood sample)

Measure: Immunophenotyping and multiplex cytokines

Time: 8 days

14 Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial

This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.

NCT04344444 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Description: ordinal outcome of most severe a patient experienced after inpatient admission

Measure: Most severe outcome

Time: 5 days

15 Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults: An Adaptive Randomized Platform Trial

This is a randomized trial for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in high-risk adults not requiring hospital admission.The overarching goal of this study is to assess the effectiveness of interventions on the incidence of lower respiratory tract infection (LRTI) progression among high-risk adult outpatients with SARS-CoV-2 infection to inform public health control strategies.

NCT04354428 COVID-19 SARS-CoV-2 Drug: Ascorbic Acid Drug: Hydroxychloroquine Sulfate Drug: Azithromycin Drug: Folic Acid

Primary Outcomes

Description: Resting blood oxygen saturation (SpO2<93%) level sustained for 2 readings 2 hours apart and presence of subjective dyspnea or cough

Measure: Lower respiratory tract infection (LRTI) rates

Time: 28 days from enrolment

Description: Cumulative incidence of hospitalization or mortality

Measure: Incidence of hospitalization or mortality

Time: Day 28 after enrolment

Description: Time to clearance of nasal SARS-CoV-2, defined as 2 consecutive negative swabs

Measure: Change in upper respiratory viral shedding

Time: Day 1 through Day 14 after enrolment

Secondary Outcomes

Description: Serious adverse events (including death and hospitalization) and adverse events resulting in treatment discontinuation

Measure: Rate of participant-reported adverse events

Time: 28 days from enrolment

16 Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia: A Pragmatic Randomized Controlled Trial

Introduction: The COVID-19 pandemic is characterized by significant morbidity and mortality. It is caused by a novel coronavirus with no current specific prevention nor treatment therapies. Treatments have been administered to patients with COVID-19 in order to control viral infection, among them: Chloroquine (CQ) and Hydroxychloroquine (HCQ), Lopinavir/Ritonavir (Lop/r), Remdesivir, Favipavir, acting over bacterial co-infection Azithromycin (Azithro), or modifying the inflammatory response of the host (Tocilizumab). Clinical trials offer conflicting evidence regarding the effectiveness and safety of therapies The real effectiveness and safety profile of the treatments for COVID-19 remains unknown. Objective: Evaluate the effectiveness and safety of pharmacological therapies used to treat adult patients with COVID-19. Methods: Pragmatic randomized controlled trial. Study population: Adults aged 18 years or over with a positive real-time polymerase chain reaction (RT-PCR) for Severe Acute Respiratory Syndrome CoV-2 (SARS CoV-2) and diagnosis of mild, severe or critical pneumonia, requiring hospital management at six hospitals in Colombia. Exclusion criteria: Pregnancy, known allergy to treatment, cirrhosis or hepatic abnormality (transaminases greater than 5 reference values), prolonged QT interval, glomerular filtration rate lesser than 30 ml/min/1.73m^2, history of lung fibrosis, advanced or metastatic cancer. Sample size: 1,600 participants. The study will be carried out in two phases. The first phase will be conducted with 480 participants and aims to identify treatments with higher or minimum potential, discontinue treatments with higher toxicity and have opportunity of introducing new treatments with potential efficacy. The second phase will be conducted with 1,120 participants to evaluate the effectiveness of the selected treatments. Four interventions have been defined: I1 HCQ, I2 HCQ plus Lop/r, I3 HCQ plus Azithro and I4 standard treatment. Within each institution, participants will be randomly assigned to one of the treatment arms assigned to that institution. Concealment will be kept through a central telephone. Treatment administration will be open. Variables: Sociodemographic and clinical at recruitment; (comorbidities, need for therapeutic support , grade of invasion at admission). Primary outcomes. Effectiveness: Mortality. Safety: Serious adverse events (AE) assessed by the NCI Community Oncology Research Program (NCORP) Guidance for Collection of Adverse Events Related to COVID-19 Infection. Secondary outcomes: Intensive care unit (ICU) admission, requirement of respiratory support, time to death, number of participants cured, any adverse event related to treatment. Analysis: Descriptive for the presentation of summary measures of the basal conditions by type of variable. Bivariate. Description of the basal conditions (with organic failure at admission, without failure at admission), by type of treatment, by participating institution. Description of crude effectiveness and safety by means of the difference of accumulated incidences, each one with 95% confidence intervals (95% CI) Intention to treat analyisis will be done. Adjusted analysis: The ratio and difference of cumulative incidences of mortality at 7 and 28 days and severe adverse events between treatments will be estimated, adjusting for confounding variables using logistic regression models with mixed effects considering each institution as a level or from equations. generalized estimation (GEE). Ethical considerations: The study has a risk beyond minimum according to the Resolution 8430/1993 of the Colombian Ministry of Health. Informed consent will be explained and signed if the patient is in condition to do so. This protocol will undergo evaluation by the ethics committee at each of the participating institutions and at the National University of Colombia. The protocol follows the Helsinki Declaration and institutional protocols for clinical investigation.

NCT04359095 COVID-19 Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Pill Drug: Azithromycin Other: Standard treatment

Primary Outcomes

Description: Cumulative incidence

Measure: Mortality

Time: Post-intervention at day 28

Description: Number of participants that develop severe adverse events related to the treatment

Measure: Number of Participants with Treatment Related Severe Adverse Events as Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection

Time: Post-intervention at day 28

Secondary Outcomes

Description: Cumulative incidence

Measure: Mortality

Time: Post-intervention at day 7

Description: Number of participants that develop severe adverse events related to the treatment

Measure: Number of Participants with Treatment Related Severe Adverse Events as Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection

Time: Post-intervention at day 7

Description: Time from the date of assignment until the date of death from any cause

Measure: Time to death

Time: Assessed up to 28 days postintervention

Description: Number of Participants that require management in the ICU

Measure: Number of Participants that are transferred to the Intensive Care Unit (ICU)

Time: Post-intervention at day 28

Description: Participants requiring invasive mechanical ventilation

Measure: Number of Participants that need Mechanical Ventilation Support with endotracheal intubation.

Time: Up to 28 days after hospital admission

Description: Number of participants cured assessed RT-PCR for SARS CoV-2, without clinical symptoms and no radiological signs assessed by chest X ray

Measure: Number of participants Cured assessed by Nasopharyngeal swab, oropharyngeal swab, and blood aspiration for COVID19 (RT-PCR) without clinical symptoms and normal chest X ray

Time: Up to 28 days after hospital admission

Description: Any adverse event

Measure: Number of Participants with Any Adverse Event Related to Treatment Assessed by the NCORP Guidance for Collection of Adverse Events Related to COVID-19 Infection

Time: Up to 28 days after hospital admission

Other Outcomes

Description: Interim assessment of safety, which will be conducted after 480 participants are recruited. It will be evaluated through absolute frequency of severe AE and relative frequency measurements (proportion of total number of participants with severe adverse events divided by the total number of participants treated). It aims to aid the decision of excluding an active treatment arm should that arm have more than 3 serious adverse events in the first 30 participants or a serious adverse events incidence of 10 percent or higher.

Measure: Severe Adverse events

Time: Up to 28 days after hospital admission

Description: Interim assessment of minimum effectiveness, which will be conducted after 480 participants are recruited. It will be evaluated through relative frequency measurements (mortality proportion at 28 days of treatment). It aims to aid the decision of excluding an active treatment arm should that treatment arm have an efficacy lower than 0.2, calculated through futility analysis that assumes an expected difference of 10 percent at the end of the first phase of the study. For all the tests carried out in the interim analysis, the correction of the type I error will be made using the O'Brien-Fleming method.

Measure: Mortality

Time: Up to 28 days after hospital admission

17 Efficacy and Safety of Azithromycin Compared to the Base Therapeutic Regiment of Hydroxychloroquine in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial

The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

NCT04359316 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

Primary Outcomes

Description: Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.

Measure: Time to clinical improvement

Time: From date of randomization until 14 days later.

Secondary Outcomes

Description: If the patient dies, we have reached an outcome.

Measure: Mortality

Time: From date of randomization until 14 days later.

Description: Pulse-oxymetry

Measure: SpO2 Improvement

Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.

Description: Incidence of new mechanical ventilation use (Rate)

Measure: Incidence of new mechanical ventilation use

Time: From date of randomization until 14 days later.

Description: Duration of hospitalization (Days)

Measure: Duration of hospitalization

Time: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days.

Description: With incidence of any serious adverse effects, the outcome has happened.

Measure: Cumulative incidence of serious adverse events

Time: Days 1, 2, 3, 4, 5, 6, 7 and 14.

18 Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19: a Randomized, Multicenter, Adaptative Study

In November 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients who died most often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%). These elderly patients with COVID19 are therefore very fragile and require treatment that fights the virus but is also adapted to their state of health and age. Most of current therapeutic trials worldwide exclude people aged over 75 years, which is precisely the age group affected by COVID19. We therefore propose to carry out a therapeutic trial specific to the elderly with drugs at doses that are bearable for these patients. Using the WHO, clinicaltrial, pubmed and the Chinese CCDC/CHCTR websites to find the better drugs adapted to elderly people, we decided after concertation between infectiologists and geriatricians to do a four arms clinical trial during two weeks twice a day: Hydroxychloroquine 200mg, Telmisartan 40mg, Azithromycin 250mg and standard care. We therefore hypothesize that one or more of these treatments may have a beneficial effect in controlling COVID19, without major and repeated side effects in elderly patients.

NCT04359953 COVID-19 Infection Drug: Hydroxychloroquine Drug: Azithromycin Drug: Telmisartan

Primary Outcomes

Measure: Two-weeks survival rate

Time: Day 14

Secondary Outcomes

Measure: Rate of undetectable RT-PCR of SARS-CoV-2

Time: Day 7

Measure: Rate of undetectable RT-PCR of SARS-CoV-2

Time: Day 14

Measure: Rate of death

Time: Day 28

Measure: Hypotension

Time: Day 7

Measure: Hypotension

Time: Day 14

Measure: Hypothermia and hyperthermia

Time: Day 7

Measure: Hypothermia and hyperthermia

Time: Day 14

Measure: Pneumonia severity according to WHO

Time: Day 7

Measure: Pneumonia severity according to PSI (Hung et al 2017)

Time: Day 7

Measure: Pneumonia severity according to WHO

Time: Day 14

Measure: Pneumonia severity according to PSI (Hung et al 2017)

Time: Day 14

Measure: Rate of no cough

Time: Day 7

Measure: Rate of no cough

Time: Day 14

Measure: Rate of no dyspnea

Time: Day 7

Measure: Rate of no dyspnea

Time: Day 14

Measure: Rate of no fever

Time: Day 7

Measure: Rate of no fever

Time: Day 14

Measure: Rate of no requiring supplemental oxygen

Time: Day 7

Measure: Rate of no requiring supplemental oxygen

Time: Day 14

Measure: Rate of SARS-Cov-2 undetectable

Time: Day 7

Measure: Rate of SARS-Cov-2 undetectable

Time: Day 14

Measure: Recovery time

Time: Day 28

Measure: Critical admission rate

Time: Day 28

Measure: Mechanical ventilation rate

Time: Day 28

Measure: Changes in Activity of Daily Living (ADL) Activity of Daily Living)

Time: Day 13

Measure: Changes in Activity of Daily Living IADL (Instrumental Activity of Daily Living)

Time: Day 13

Measure: The number and dose of added corticosteroids, immonumodulators or immunosuppressants

Time: Day 14

19 VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)

We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.

NCT04363203 SARS-CoV-2 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Drug: Placebo oral tablet

Primary Outcomes

Measure: Days to resolution of cough, fever and shortness of breath

Time: 30-days

Secondary Outcomes

Measure: Days to resolution of all COVID-19 symptoms

Time: 30-days

Measure: All cause hospitalization

Time: 30-days

Measure: All cause mortality

Time: 30-days

Measure: COVID-19 specific mortality

Time: 30-days

Measure: COVID-19 specific hospitalization

Time: 30-days

20 A Randomized Trial of Efficacy and Safety of an Early OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome: a Strategy to Prevent Hospitalization

COVID-19 is a respiratory disease due to a novel coronavirus (SARS-CoV-2) that causes substantial morbidity and mortality. To date, no treatment has been proved to be effective in COVID-19. Elderly patients and patients with comorbidities have the worse prognosis with a higher risk of hospitalization, ICU admission and death. The efficacy of an early outpatient treatment could be suggested but need to be confirmed. This confirmation is mandatory to improve prognosis of COVID-19 but also to avoid unsuspected deleterious effect of drugs already used in clinical practice but not based on evidence.

NCT04365582 COVID Drug: Azithromycin Drug: Hydroxychloroquine Drug: Lopinavir 200Mg/Ritonavir 50Mg Tab

Primary Outcomes

Description: Hospitalization at D20

Measure: Hospital admission

Time: Day 20

Secondary Outcomes

Description: This outcome corresponds to the number of patients who died on day 20.

Measure: Effect of treatment on Death at D20

Time: Day 20

Description: This outcome corresponds to the number of patients who died on day 60.

Measure: Effect of treatment on Death at D60

Time: Day 60

Description: This outcome corresponds to the number of patients who died due to COVID on day 20.

Measure: Effect of treatment on Death due to COVID at D20

Time: Day 20

Description: This outcome corresponds to the number of patients who died due to COVID on day 60.

Measure: Effect of treatment on Death due to COVID at D60

Time: Day 60

Description: This outcome corresponds to the number of participants who need ICU stay at day 20.

Measure: Effect of treatment on need for ICU stay at D20

Time: Day 20

Description: This outcome corresponds to the number of participants who need ICU stay at day 60.

Measure: Effect of treatment on need for ICU stay at D60

Time: Day 60

Description: This outcome evaluates the duration of patient's ICU stay at day 20.

Measure: Effect of treatment on duration of ICU stay at D20

Time: Day 20

Description: This outcome evaluates the duration of patient's ICU stay at day 60.

Measure: Effect of treatment on duration of ICU stay at D60

Time: Day 60

Description: This outcome corresponds to the number of participants who need mechanical ventilation at D20.

Measure: Effect of treatment on need of mechanical ventilation at D20

Time: Day 20

Description: This outcome corresponds to the number of participants who need mechanical ventilation at D60.

Measure: Effect of treatment on need of mechanical ventilation at D60

Time: Day 60

Description: This outcome corresponds to the duration of patient's mechanical ventilation at D20.

Measure: Effect of treatment on duration of mechanical ventilation at D20

Time: Day 20

Description: This outcome corresponds to the duration of patient's mechanical ventilation at D60.

Measure: Effect of treatment on duration of mechanical ventilation at D60

Time: Day 60

Description: This outcome evaluates the delay between inclusion and hospitalization at D20.

Measure: Effect of treatment on time to hospitalization at D20

Time: Day 20

Description: This outcome evaluates the delay between inclusion and hospitalization at D60.

Measure: Effect of treatment on time to hospitalization at D60

Time: Day 60

Description: This outcome evaluates the duration of patient's Hospital stay at D20.

Measure: Effect of treatment on Duration of Hospital stay et D20

Time: Day 20

Description: This outcome evaluates the duration of patient's Hospital stay at D60.

Measure: Effect of treatment on Duration of Hospital stay et D60

Time: Day 60

Description: This outcome evaluates the duration of symptoms at D20 after treatment.

Measure: Effect of treatment on Duration of symptoms at D20

Time: Day 20

Description: This outcome evaluates the duration of symptoms at D60 after treatment.

Measure: Effect of treatment on Duration of symptoms at D60

Time: Day 60

Description: This outcome measures the number of participants with treatment-related adverse events as assessed by CTCAE v4.0, at the end of study.

Measure: Incidence of Treatment-Emergent Adverse Events

Time: Month 6

Other Outcomes

Description: This outcome evaluates the chest radiological features on Chest HRCT, at 6 months, after treatment.

Measure: Effect of treatment on chest radiological features

Time: Month 6

Description: This outcome evaluates the Pulmonary function test at 6 month, after treatment.

Measure: Effect of treatment on respiratory capacity

Time: Month 6

Description: This ouctome eavaluates costs and consequences which will be presented for each stakeholder in a disaggregated way at the end of study.

Measure: Cost consequence analysis

Time: Month 6

21 Oxygen-Ozone as Adjuvant Treatment in Early Control of Disease Progression in Patients With COVID-19 Associated With Modulation of the Gut Microbial Flora

Italy was the first European country affected by a severe outbreak of the Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic emerged from Wuhan region (China), with a high morbidity and mortality associated with the disease. In light of its pandemic spread and the very limited therapeutic options, COronaVIrus Disease 19 (COVID-19) is considered an unprecedented global health challenge. Therefore, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an interventional, non-pharmacological, open, randomized, prospective, non-profit study on the adjuvant use of oxygen ozone therapy plus probiotic supplementation in the early control of disease progression in patients with COVID-19. Contextually, all patients are treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of an ozone therapy-based intervention (accompanied by supplementation with probiotics) in containing the progression of COVID-19 and in preventing the need for hospitalization in intensive care units.

NCT04366089 COVID SARS-CoV 2 Pneumonia, Viral Coronavirus Infection Other: Oxygen-ozone therapy, probiotic supplementation and Standard of care Dietary Supplement: SivoMixx (200 billion) Drug: Azithromycin Drug: hydroxychloroquine
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Comparison between the two groups

Measure: Delta in the number of patients requiring orotracheal intubation despite treatment

Time: 21 days

Secondary Outcomes

Description: Comparison between the two groups

Measure: Delta of crude mortality

Time: 21 days

Description: Comparison between the two groups

Measure: Delta of length of stay for patients in hospital

Time: 90 days

Description: Comparison between the two groups

Measure: delta in the value of interleukin (IL)-1

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-6

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of IL-10

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of Tumor Necrosis Factor (TNF)-alpha

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of cluster of differentiation (CD)4+ CD38/ Human Leukocyte Antigen-DR isotype (HLA-DR)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of CD8+ CD38/ HLA-DR

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of fecal calprotectin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of lipopolysaccharide (LPS)

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of zonulin

Time: 21 days

Description: Comparison between the two groups

Measure: delta in the value of alpha1-antitrypsin

Time: 21 days

22 Evaluation of the Impact of Bacteriotherapy in the Treatment of COVID-19

In light of its high morbidity and mortality, COronaVIrus Disease 19 (COVID-19) pandemic spread is considered an unprecedented global health challenge. Given the very limited therapeutic options available against Severe Acute Respiratory Syndrome - CoronaVirus-2 (SARS-CoV-2) epidemic at this time, the evaluation of new resources, designed in the first instance for other pathologies but potentially active against COVID-19, represents a priority in clinical research. This is an observational, retrospective, non-profit study on the adjuvant use of bacteriotherapy in the early control of disease progression in patients affected by COVID-19 and treated with the current standard of care on the basis of the interim guidelines of the Italian Society of Infectious and Tropical Diseases. The main purpose of the study is to evaluate the effectiveness of bacteriotherapy in reducing the clinical impact of acute diarrhea, containing the progression of COVID-19 and preventing the need for hospitalization in intensive care units.

NCT04368351 COVID Pneumonia Diarrhea Dietary Supplement: SivoMixx (200 billion) Drug: Azithromycin Drug: hydroxychloroquine
MeSH:Pneumonia Diarrhea
HPO:Diarrhea Pneumonia

Primary Outcomes

Description: Comparison between the two groups. Acute diarrhea was defined as a stool with increased water content, volume, or frequency that lasts less than 14 days.

Measure: delta of time of disappearance of acute diarrhea

Time: 21 days

Secondary Outcomes

Description: Comparison between the two groups

Measure: Delta in the number of patients requiring orotracheal intubation despite treatment

Time: 21 days

Description: Comparison between the two groups

Measure: Delta of crude mortality

Time: 21 days

Description: Comparison between the two groups

Measure: Delta of length of stay for patients in hospital

Time: 21 days

23 A Randomized Study Evaluating the Safety and Efficacy of Hydroxychloroquine and Zinc in Combination With Either Azithromycin or Doxycycline for the Treatment of COVID-19 in the Outpatient Setting

This is a randomized, open-label trial to assess the safety and efficacy of hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a higher risk COVID-19 positive outpatient population.

NCT04370782 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Drug: Zinc Sulfate Drug: Doxycycline

Primary Outcomes

Description: Patients will be assessed on day 5 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)

Measure: Time to Resolution of Symptoms relative to baseline (day 1 of trial)

Time: Day 5

Description: Patients will be assessed on day 14 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)

Measure: Time to Resolution of Symptoms relative to baseline (day 1 of trial)

Time: Day 14

Description: Patients will be assessed on day 21 for when COVID-19 symptoms completely resolve compared to baseline (day 1 of trial)

Measure: Time to Resolution of Symptoms relative to baseline (day 1 of trial)

Time: Day 21

Description: Number of participants hospitalized and/or requiring repeat ER visits related to COVID-19 complications

Measure: Number of participants hospitalized and/or requiring repeat ER visits

Time: 21 days

Description: If hospitalized, number of participants admitted to the ICU, and number of days in the ICU

Measure: ICU Length of Stay

Time: Until Discharged up to 30 days

Description: If placed on ventilator, number of days on a ventilator

Measure: Ventilator

Time: Until extubated up to 30 days

Secondary Outcomes

Description: Severity of symptoms evaluated at day 5, day 14, and day 21 scored by the participant for feverishness, sore throat, cough, shortness of breath, myalgias. (0 =none; 1 = mild; 2 = moderate; 3 = severe)

Measure: Severity of symptoms

Time: Day 5, Day 14, and Day 21

Description: Number of participants with adverse events due to drug regimen

Measure: Number of participants with adverse events due to drug regimen

Time: 21 days

Description: Assess all patients to evaluate for QTc prolongation >500ms

Measure: Number of participants with QTc prolongation >500ms

Time: Days 1 thru 5, Day 10, Day 21

24 Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial

On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world. To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted. It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Therefore azithromycin (AZM) is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases). The aim of this study is to demonstrate that AZM decreases symptom duration in COVID19 patients and diminishes the viral carriage.

NCT04371107 Covid19 Azithromycin Ambulatory Other: consultation Drug: Azithromycin

Primary Outcomes

Description: Length of symptom duration (in days) with azithromycin treatment

Measure: Length of symptom duration (in days) with azithromycin treatment

Time: up to 2 months

25 A Randomised Controlled Trial of Early Intervention in Patients HospItalised With COVID-19: Favipiravir Verses HydroxycholorquiNe & Azithromycin & Zinc vErsEs Standard CaRe

Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either a combination of azithromycin, hydroxychloroquine and zinc or favipiravir, alongside usual care, can help patients with suspected or proven COVID-19 infection.

NCT04373733 Coronavirus Infection Drug: Favipiravir Drug: Hydroxychloroquine Drug: Azithromycin Drug: Zinc Sulfate Other: Standard of care management
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Time from randomisation to clinical improvement by two points on a seven-category ordinal scale: Not hospitalised with resumption of normal activities Not hospitalised, but unable to resume normal Hospitalised, not requiring supplemental oxygen Hospitalised, requiring supplemental oxygen Hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation or both Hospitalised, requiring ECMO (Extra-corporal membrane oxygenation), invasive mechanical ventilation or both Death

Measure: Time to improvement by two points on a seven-category ordinal scale

Time: Up to 28 days from randomisation

Secondary Outcomes

Description: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)

Measure: Clinical status on a seven-category ordinal scale (Day 7)

Time: Day 7 from randomisation

Description: Clinical status of patients at given on the seven-category ordinal scale (see primary endpoint for scale)

Measure: Clinical status on a seven-category ordinal scale (Day 14)

Time: Day 14 from randomisation

Description: Survival of patients to end of study

Measure: Overall survival

Time: 28 days from randomisation

Description: Time from randomisation to improvement by two points on the NEWS score of patient condition, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Measure: Time to improvement by two points on the NEWS score

Time: Up to 28 days from randomisation

Description: Time from randomisation to improvement by two points on the NEWS element score for temperature, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Measure: Time to improvement by two points on the NEWS element score for temperature

Time: Up to 28 days from randomisation

Description: Time from randomisation to improvement by two points on the NEWS element score for heartrate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Measure: Time to improvement by two points on the NEWS element score for heartrate

Time: Up to 28 days from randomisation

Description: Time from randomisation to improvement by two points on the NEWS element score for respiratory rate, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Measure: Time to improvement by two points on the NEWS element score for respiratory rate

Time: Up to 28 days from randomisation

Description: Time from randomisation to improvement by two points on the NEWS element score for oxygen saturation, if maintained for 24 hours. For details of NEWS score see https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

Measure: Time to improvement by two points on the NEWS element score for oxygen saturation.

Time: Up to 28 days from randomisation

Description: Frequency of admission of patients to intensive care

Measure: Admission to intensive care

Time: Up to 28 days from randomisation

Description: Frequency of requirement to administer mechanical ventilation to patients

Measure: Requirement for mechanical ventilation

Time: Up to 28 days from randomisation

Description: Frequency of requirement to administer non-invasive ventilation, continuous positive airways pressure or high-flow oxygen to patients

Measure: Requirement for non-invasive ventilation, continuous positive airways pressure or high-flow oxygen

Time: Up to 28 days from randomisation

Description: Frequency of culture-confirmed bacterial or fungal infection in patients

Measure: Incidence of bacterial or fungal infection

Time: Up to 28 days from randomisation

Description: Frequency and severity of adverse events in patients not directly attributed by clinicians to COVID-19 infection.

Measure: Incidence of adverse events not directly caused by COVID-19 infection.

Time: Up to 28 days from randomisation.

Other Outcomes

Description: Frequency of readmission to inpatient care of patients discharged from hospital.

Measure: Readmission to inpatient care

Time: Up to 28 days from randomisation

26 Randomized Evaluation of COVID-19 Therapy

RECOVERY is a randomised trial investigating whether treatment with either Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin or Tocilizumab prevents death in patients with COVID-19.

NCT04381936 Severe Acute Respiratory Syndrome Drug: Lopinavir-Ritonavir Drug: Corticosteroid Drug: Hydroxychloroquine Drug: Azithromycin Drug: Tocilizumab
MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

Primary Outcomes

Description: For each pairwise comparison with the 'no additional treatment' arm, the primary objective is to provide reliable estimates of the effect of study treatments on all-cause mortality.

Measure: All-cause mortality

Time: Within 28 days after randomisation

Secondary Outcomes

Description: To assess the effects of study treatment on number of days stay in hospital

Measure: Duration of hospital stay

Time: Within 28 days after randomisation

Description: To assess the effects of study treatment on number of patients who needed ventilation and the number of days it was required

Measure: Need for (and duration of) ventilation

Time: Within 28 days after randomisation

Description: To assess the effects of study treatment on number of patients who needed renal replacement therapy

Measure: Need for renal replacement

Time: Within 28 days after randomisation

27 Novel Treatment Regimens in Treatment of COVID-19

Azithromycin has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.

NCT04382846 COVID Corona Virus Infection Drug: Nitazoxanide Drug: Ivermectin Drug: Chloroquine Drug: Azithromycin
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: the number of patients with virological cure

Measure: Number of patients with virological cure

Time: 6 months

28 Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers

The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose < 1 Gy. The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.

NCT04394182 Pneumonia, Viral Cytokine Storm Radiation: Ultra-Low-dose radiotherapy Device: ventilatory support with oxygen therapy Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine Drug: Azithromycin Drug: Piperacillin/tazobactam Drug: Low molecular weight heparin Drug: Corticosteroid injection Drug: Tocilizumab
MeSH:Pneumonia, Viral Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 2

Time: At 2 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2

Time: At 2 days after RT

Secondary Outcomes

Description: Pa02 / Fi02 > 300 mmHg

Measure: Blood Gas Analysis at Day 2

Time: At 2 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 2

Time: At 2 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 5

Time: At 5 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5

Time: At 5 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 5

Time: At 5 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 7

Time: At 7 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7

Time: At 7 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 7

Time: At 7 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)

Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7

Time: At 7 days after RT

Description: Recovery time after RT administration until hospital discharge or death (<48h; 2-7 days; >7 days; clinical worsening or death)

Measure: Recovery time

Time: From RT administration until hospital discharge or death

Description: COVID-19 negativization test

Measure: COVID-19 status

Time: At 7 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)

Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1

Time: At 1 month after RT

Description: Toxicity was assessed and rated according to the NIH Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and RTOG scales.

Measure: Acute Toxicity

Time: 1-3 months after RT


Related HPO nodes (Using clinical trials)


HP:0002014: Diarrhea
Genes 355
MEFV JAK3 IL2RG CD247 NCF4 PIGT IL2RG MYO5B PMM2 GALT JAK3 MYO5B ITGA2 PTEN ABCB4 USP7 CD40LG IGHM HEXB MLYCD SKIV2L TTC37 TMPRSS15 DCLRE1C MC2R ZAP70 KIF1B NOD2 IL6 ABCC8 HSD3B7 PRKN EFL1 SLC12A3 CARMIL2 POLG LRRC8A ANTXR2 ATP8B1 OTULIN SNCA WNT2B MRAP SLC46A1 CHD7 SERPING1 FOXP3 UCP2 IGKC CPOX ABCB11 IRAK1 CD3D DAXX UCHL1 VPS13C SLC9A3 SMAD4 TSHR SCNN1G CD79B DDC DGAT1 SRP54 ANTXR2 SLC12A1 IL7R BMPR1A BMPR1A AKR1D1 SMAD4 SLC39A4 ICOS ADA DNASE1L3 IL7R GATA6 GREM1 ITGB4 EPCAM B2M ALG3 RFX5 ARX LCK ELP1 DCLRE1C CLCNKB SERPING1 EDN3 MVK LIG4 GINS1 TYMP KRAS PALB2 ELANE CASP8 SCNN1A MCM6 CYP11B2 CD79A PODXL CFH SMAD4 SERPING1 HTRA2 LRBA ACADM SLC5A1 NEUROG3 NBN FBP1 BLNK ITGA2B RET RFXAP DCLRE1C ALG8 SLC26A3 RMRP TCF3 C5 TSHR MEN1 PLVAP RECQL4 ACTG2 EDNRB CDKN2B RET GNS SLC10A2 LCT SCNN1B RAG2 DBH ADA EGFR STAT1 TTC37 STAR WAS RFXANK ALDOB IL21R RFXANK SGSH CDKN1A RFX6 POLG KIF23 PARK7 ACSF3 TTR ATP7A ACSF3 RAG1 TTR CIITA IDUA RFXAP ADA DNMT3B RAG2 NLRC4 CR2 BTK C1R GFI1 LIPA IL2RG TNFRSF13C ATRX SON ACVRL1 SKIV2L PIK3R1 SAR1B KCNJ11 SLC46A1 CD55 TERT SLC7A7 MEN1 COG4 SAA1 GDNF ACAT1 NEUROG3 NAXD SCN11A ITCH CD79A CDKN1B GLA RNF113A RAG1 MGME1 SAR1B ETHE1 RAG1 NNT TLK2 GUCY2C BTK TFRC SMAD4 NHLRC2 CD19 KCNJ1 MVK ETHE1 CLMP STAT4 MVK PHKB IL10RA BRCA2 STAT1 CD79B HLA-B MGME1 SLC39A4 WAS IL21 SMARCD2 SEMA3D AK2 ZAP70 TREH GP1BB IL2RA HMGCL TCN2 BLM TNFRSF1A AGA SUGCT TYMP SLC25A13 MYD88 SAMD9 TNFRSF13B LIPA HPS1 COG6 IKZF1 SLC7A7 NOD2 BTK MPI LRRK2 HMBS RFX5 PPP2R5D ITGA6 CFHR1 ICOS BMPR1A LIG4 TXNRD2 ITGB3 CR2 RAG1 PCSK1 SDHD NAGLU RIPK1 OPLAH AIRE CDKN1B DNAJC6 ERCC2 ALAD HYOU1 HGSNAT C1QA TP53 PPP2R5D AP1S1 CYP27A1 RAG2 SEMA3C RECQL4 CFHR3 SCN9A BMPR1A AVP CCDC47 TCIRG1 RAG2 MAOA RRM2B IKBKB CTLA4 DES PINK1 PKP1 NR3C2 CYP7B1 CIITA SI HADH ADAM17 FOXP3 CPT1A G6PC CD3E PALLD COG4 SPP1 CD247 PIK3R1 STX3 HNF1A NAGS TTC7A TTC7A RNF168 ECE1 PLEC APC HNF4A SLC19A2 IFNGR1 CD3D WIPF1 SLC25A13 SPINT2 NRTN NSUN2 TGFB1 POLA1 NBN IGHM CDKN2A MPV17 BLNK IDS IL7R SP110 F5 PTPRC CDKN2C IGLL1 IL2RB BTD HMGCS2 ENG BRCA1 ENG CD109 CYP27A1 GP1BA
Protein Mutations 1
R192G
SNP 0