anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Favipiravir
Trial phase: Phase 2
ATC code: J05AX27
SMILES: NC(=O)c1nc(F)cnc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Day 1: favipiravir 1800 mg BID plus Standard of Care (SOC) Days 2-14: 1000 mg BID plus SOC. For subjects with Child-Pugh A liver impairment: Days 2-14: 800 mg BID plus SOC

Favipiravir: Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets
Eligibility criteria:
Inclusion Criteria:

1) Adults (18 to 80 years old):

within 72 hours of their hospitalization for infection with Severe Acute Respiratory Syndrome - Corona Virus - 2 (SARS-CoV-2), AND,
within 72 hours of the latest Polymerase Chain Reaction (PCR) positive result and within 7 days of the 1st PCR positive result for SARS-CoV-2. (The latest PCR could be the only PCR result.), AND,
within 10 days of onset of any COVID-19 symptoms.

Exclusion Criteria:

Subject has a concomitant bacterial respiratory infection unless cleared by the Sponsor
Subject has a history of abnormalities of uric acid metabolism unless cleared by the Sponsor.
Subject has a history of hypersensitivity to an anti-viral nucleoside analog drug targeting a viral RNA polymerase
Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). Dexamethasone 6 mg daily (PO or IV) for 10 days is permitted.
Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, moderate or severe hepatic insufficiency and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days).
Has previously received favipiravir within the past 30 days
Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) or glomerular filtration rate of less than 20 mL/min.
Has liver impairment greater than Child-Pugh A.
Has a history of alcohol or drug abuse in the previous 6 months.
Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
Has taken another investigational drug within the past 30 days.
Is on another antiviral or is participating in another clinical trial for the treatment of COVID-19
Subject is on a ventilator at the time of study entry
Is deemed by the Investigator to be ineligible for any reason.
Intervention: Lovastatin
Trial phase: Phase 1
ATC code: C10AA02 | C10BA01
SMILES: [H][C@@]12C(=C[C@H](C)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: This arm will utilize 2% lovastatin ointment. It will be compounded by a pharmacist. Ointment will be applied on lesional skin with occlusion twice daily for 12 weeks.

Lovastatin 2%: Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.
Eligibility criteria:
Inclusion Criteria:

All patients 18 years and older with the diagnosis of disseminated superficial actinic porokeratosis.

Exclusion Criteria:

Patients with allergies or contraindications to lovastatin or cholesterol
Female patients currently pregnant or lactating.
Female patients with plans to become pregnant.
Patients actively taking approved forms of long-term contraception (oral contraceptives, implantable intrauterine devices, or other hormone eluting implants) will be allowed to participate as long as they have no plan to become pregnant during the course of the study. A urine pregnancy test will be administered to these patients to confirm that they can be included in the study.
Inability or unwillingness of subject or legal guardian/representative to give informed consent
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: The control group will receive normal saline placebo subcutaneously every 6 hours for period of 10 days. For subjects meeting complete response criteria at 5 days, dosing will be decreased to twice daily for the remaining 5 days.

Normal saline: The control group will receive normal saline placebo subcutaneously every 6-12 hours for period of 10 days
Eligibility criteria:
Inclusion Criteria:

18 years old or older
Molecular (pcRNA) diagnosis of SARS-CoV-2 infection
Chest imaging studies consistent with Covid-19 pneumonia
Hyperferritinemia (>700 ng/ml)
History of fever >38 degrees C

Any three of the following:

Elevated d-dimer (> 500 ng/ml)
thrombocytopenia (< 130,000/mm3)
leucopenia (WBC <3500/mm3) or lymphopenia (<1000/mm3)
elevated AST or ALT (> 2X ULN)
elevated LDH (> 2X ULN)
CRP > 100 mg/L

Exclusion Criteria:

Participation in other investigational treatment protocols for Covid-19 infection
Culture confirmed active bacterial infection requiring antibiotic therapy
On mechanical ventilation
Previous known hypersensitivity reaction to anakinra
Previous known hypersensitivity reaction to E Coli derived proteins
Pregnant or breast-feeding females
Intervention: Ruxolitinib
Trial phase: Phase 3
ATC code: D11AH09 | L01EJ01 | L01XE18
SMILES: N#CC[C@H](C1CCCC1)n1cc(-c2ncnc3[nH]ccc23)cn1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 281
Group description: Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
Eligibility criteria:
Inclusion Criteria:

Patient or guardian/health proxy must provide informed consent (and assent if applicable) before any study assessment is performed.

Male and female patients aged ≥ 12 years (or ≥ the lower age limit allowed by Health Authority and/or Ethics Committee/Institutional Review Board approvals).

Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test from the respiratory tract prior to randomization.

Patients currently hospitalized or will be hospitalized prior to randomization.

Patients, who meet at least one of the below criteria:

Pulmonary infiltrates (chest X ray or chest CT scan);
Respiratory frequency ≥ 30/min;
Requiring supplemental oxygen;
Oxygen saturation ≤ 94% on room air;
Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m).

Exclusion Criteria:

History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.

Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8 μmol/L), or have estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation or calculated by the updated bedside Schwartz equation.

Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).

Currently intubated or intubated between screening and randomization. In intensive care unit (ICU) at time of randomization. Intubated or in ICU for COVID-19 disease prior to screening. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).

Unable to ingest tablets at randomization. Pregnant or nursing (lactating) women
Intervention: Colchicine
Trial phase: Phase 2
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: Colchicine: People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
Eligibility criteria:
Males and females >=18 years of age
Willing and able to provide written informed consent prior to performing study procedures
Currently hospitalized and requiring medical care for COVID-19
Significant COVID-19 symptom, or judged by the treating provider to be at high risk of progression to severe COVID-19 infection

Significant COVID-19 symptoms are defined by one or more of the following:

Dyspnea
Respiratory frequency ≥ 30/min
Blood oxygen saturation ≤ 93%
AND one or more of the following: (positive PCR test or positive antibodies) or (CT/Chest X-ray consistent with COVID19 infection) or (anosmia).

Exclusion Criteria:

Requirement of oxygen supplementation >8L nasal cannula
Pregnancy
Known hypersensitivity to colchicine
Patient currently in shock or with hemodynamic instability requiring pressors
History of cirrhosis
Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5X upper limit of normal (ULN)
Patients with severe renal disease, CrCl <30ml/min
Patients requiring invasive mechanical ventilation at screening or Clinical estimation that the patient will require mechanical respiratory support within 24 hours
Patient is currently taking colchicine for other indications (gout or Familial Mediterranean Fever)
Patient received Remdesivir, Sarilumab, Tociluzimab, Lopinavir/Ritonavir or other immunomodulator given for COVID-19 treatment (Note: Convalescent plasma infusion is not an exclusion)
Patient is on (and cannot discontinue) a strong CYP3A4 inhibitor (eg clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhbitor (eg diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a P-gp Inhibitor (eg cyclosporine, ranolazine)
Patient is undergoing chemotherapy for cancer
Patient is considered by the investigator, for any reason, to be unsuitable candidate for the study
Intervention: AT-001
Trial phase: Phase 2
SMILES: O=C(O)Cc1nn(Cc2nc3cc(C(F)(F)F)ccc3s2)c(=O)c2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement >200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.

AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team
Eligibility criteria:
Inclusion Criteria

Registry Study: In order to be eligible to participate in the registry study, an individual must meet all of the following criteria:

Age ≥18 years of age
Hospitalized at one of the participating NYULH locations
Confirmed COVID-19 infection

Interventional Study: In order to be eligible to participate in the registry study, and individual must meet all of the inclusion criteria of the registry study plus the following criteria:

Hospitalized at NYU Tisch
History of diabetes mellitus or blood glucose measurement >126 mg/dl AND EITHER
History of hypertension and/or ischemic heart disease and/or heart failure OR
Other co-morbid condition that in the opinion of the PI increases risk of heart or lung injury related to the aldose reductase pathway

Exclusion Criteria

Registry Study: An individual who meets any of the following criteria will be excluded from participation in the registry study:

Persons who have opted out of research participation at NYU
Pregnancy

Interventional study: An individual who meets any of the following criteria will be excluded from participation in the interventional study:

Persons who have opted out of research participation at NYU
Pregnancy
Women of childbearing potential
Breast-feeding women
Participation in another investigational drug protocol within previous 30 days
Intervention: Naltrexone
Trial phase: Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Naltrexone 4.5 mg by mouth 1 time per day for patients with stage I or stage 2A COVID-19.

Naltrexone: Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
Eligibility criteria:
Inclusion Criteria:

Positive for COVID -19
Admitted to Beaumont Hospital - Royal Oak, Michigan
Age ≥18
Receiving ≤ 6 liters/minute oxygen by nasal cannula for randomization to either placebo or naloxone arm OR receiving ≥ 6 liters/minute oxygen by nasal cannula or requiring advanced oxygenation for placement in ketamine arm

Exclusion Criteria:

Known allergy to naltrexone
Known allergy to ketamine
Diagnosis of schizophrenia or psychosis
Pregnancy based on available medical history, existing labs, or verbal report
On chronic high dose opioids > 90mg morphine mg equivalence
Use of naltrexone or Vivitrol within 90 days
Intervention: Bupivacaine hydrochloride
Trial phase: Phase 4
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: Bupivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
Eligibility criteria:
Inclusion Criteria:

Elective C section via Pfannenstiel incision
Living singleton pregnancy
Gestation week at least 37 weeks
American Society of Anesthesiologists (ASA) status 1, 2 and 3
Primary and secondary C sections

Exclusion Criteria:

Chronic pain
Opioid tolerant patients
Allergy to drugs used in the study.
Cognitive dysfunction
BMI > 40
Coagulation disorder
Local infection
Inability to tolerate oral medication
Previous intra-abdominal surgery
Patients who will receive a combined spinal epidural for their C section
Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.- local wound infiltration by surgeon)
Patients who received sedation or general anesthesia during their C section (midazolam, ketamine, fentanyl, propofol, hydromorphone)
Intervention: Ropivacaine hydrochloride
Trial phase: Phase 4
SMILES: CCCN1CCCCC1C(=O)Nc1c(C)cccc1C.Cl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: ropivacaine hydrochloride: Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
Eligibility criteria:
Inclusion Criteria:

Elective C section via Pfannenstiel incision
Living singleton pregnancy
Gestation week at least 37 weeks
American Society of Anesthesiologists (ASA) status 1, 2 and 3
Primary and secondary C sections

Exclusion Criteria:

Chronic pain
Opioid tolerant patients
Allergy to drugs used in the study.
Cognitive dysfunction
BMI > 40
Coagulation disorder
Local infection
Inability to tolerate oral medication
Previous intra-abdominal surgery
Patients who will receive a combined spinal epidural for their C section
Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.- local wound infiltration by surgeon)
Patients who received sedation or general anesthesia during their C section (midazolam, ketamine, fentanyl, propofol, hydromorphone)
Intervention: Artecom
Trial phase: Phase 3
SMILES: CC1CCC2C(C)C(OC(=O)CCC(=O)O)OC3OC4(C)CCC1C32OO4.COc1ccc2nc3cc(Cl)ccc3c(Nc3cc(CN4CCCC4)c(O)c(CN4CCCC4)c3)c2n1.O=P(O)(O)O.O=P(O)(O)O.O=P(O)(O)O.O=P(O)(O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days.
Eligibility criteria:
Inclusion Criteria:

Male or female patients between the age of 3 and 60 years, inclusive.
Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.

Presence of acute uncomplicated P. vivax mono-infection confirmed by:

Fever, as defined by axillary/tympanic temperature ≥37.5°C or oral/rectal temperature ≥38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
Positive microscopy of P. vivax with parasite density ≥250/ μL of blood (including at least 50% of asexual parasites).
Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations.
Ability to swallow oral medication.
Ability and willingness to participate based on information given to patient or parent or guardian and access to health facility.

Exclusion Criteria:

Presence of a mixed Plasmodium infection.
Presence of other clinical condition requiring hospitalization.
Presence of significant anaemia, as defined by Hb <8 g/dL.
Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval greater than or equal to 450 msec), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including recent head trauma).
Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, chloroquine or artesunate or other artemisinins.
Known history of hypersensitivity, allergic or adverse reactions to chloroquine, primaquine and related agents.
Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab).
Known seropositive HIV antibody.
Have received any antimalarial treatment in the preceding 2 weeks, as determined by history and, whenever feasible, by screening test.
Have received antibacterial with known antimalarial activity in the preceding 2 weeks.
Have received any investigational drug within the past 4 weeks.
Liver function tests (AST/ALT levels) >2.5 times the upper limit of normal range.
Known significant renal impairment as indicated by serum creatinine levels of >1.4 mg/dL.
Female patients of child-bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures to not become pregnant during the study period.
Previous participation in the present clinical trial with pyronaridine artesunate.
Intervention: Chloroquine
Trial phase: Phase 3
ATC code: P01BA01 | P01BB52
SMILES: CCN(CC)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days.
Eligibility criteria:
Inclusion Criteria:

Male or female patients between the age of 3 and 60 years, inclusive.
Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.

Presence of acute uncomplicated P. vivax mono-infection confirmed by:

Fever, as defined by axillary/tympanic temperature ≥37.5°C or oral/rectal temperature ≥38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
Positive microscopy of P. vivax with parasite density ≥250/ μL of blood (including at least 50% of asexual parasites).
Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations.
Ability to swallow oral medication.
Ability and willingness to participate based on information given to patient or parent or guardian and access to health facility.

Exclusion Criteria:

Presence of a mixed Plasmodium infection.
Presence of other clinical condition requiring hospitalization.
Presence of significant anaemia, as defined by Hb <8 g/dL.
Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval greater than or equal to 450 msec), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including recent head trauma).
Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, chloroquine or artesunate or other artemisinins.
Known history of hypersensitivity, allergic or adverse reactions to chloroquine, primaquine and related agents.
Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab).
Known seropositive HIV antibody.
Have received any antimalarial treatment in the preceding 2 weeks, as determined by history and, whenever feasible, by screening test.
Have received antibacterial with known antimalarial activity in the preceding 2 weeks.
Have received any investigational drug within the past 4 weeks.
Liver function tests (AST/ALT levels) >2.5 times the upper limit of normal range.
Known significant renal impairment as indicated by serum creatinine levels of >1.4 mg/dL.
Female patients of child-bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures to not become pregnant during the study period.
Previous participation in the present clinical trial with pyronaridine artesunate.