TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase I/II, Open Label Study to Evaluate Safety, Tolerability and Therapeutic Effects of Transplantation of Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients.
Brief Summary: The study will evaluate the safety, tolerability and therapeutic effects (preliminary efficacy) of injection of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF), as a possible treatment for patients with Amyotrophic Lateral Sclerosis (ALS) at the early and progressive disease stages.


Options:
A: Arm Label: Transplant; Type: EXPERIMENTAL; Interventions: Procedure: Laminectomy and bone marrow stem cells transplantation, Procedure: Autologous bone marrow cells collection | Intervention Type: PROCEDURE; Name: Laminectomy and bone marrow stem cells transplantation; Assigned to Arm(s): Transplant | Intervention Type: PROCEDURE; Name: Autologous bone marrow cells collection; Assigned to Arm(s): Transplant
B: Arm Label: Treatment with autologous mesenchymal stem cells (MSC) intrathecally and intravenously; Type: EXPERIMENTAL; Interventions: Biological: Injection of autologous bone marrow derived mesenchymal stem cells | Intervention Type: BIOLOGICAL; Name: Injection of autologous bone marrow derived mesenchymal stem cells; Assigned to Arm(s): Treatment with autologous mesenchymal stem cells (MSC) intrathecally and intravenously
C: Arm Label: MSC-NTF; Type: EXPERIMENTAL; Interventions: Biological: MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal injection into the CSF | Intervention Type: BIOLOGICAL; Name: MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal injection into the CSF; Assigned to Arm(s): MSC-NTF
D: Arm Label: MSC-NTF cells IM; Type: EXPERIMENTAL; Interventions: Biological: MSC-NTF cells transplantation (IM) | Arm Label: MSC-NTF cells IT; Type: EXPERIMENTAL; Interventions: Biological: MSC-NTF cells transplantation (IT) | Intervention Type: BIOLOGICAL; Name: MSC-NTF cells transplantation (IM); Assigned to Arm(s): MSC-NTF cells IM | Intervention Type: BIOLOGICAL; Name: MSC-NTF cells transplantation (IT); Assigned to Arm(s): MSC-NTF cells IT

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase I/II, Open Label Study to Evaluate Safety, Tolerability and Therapeutic Effects of Transplantation of Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients.
Brief Summary: The study will evaluate the safety, tolerability and therapeutic effects (preliminary efficacy) of injection of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF), as a possible treatment for patients with Amyotrophic Lateral Sclerosis (ALS) at the early and progressive disease stages.


Options:
A: Arm Label: stem cell reciepient; Type: EXPERIMENTAL; Interventions: Biological: intra venous injection of stem cell | Intervention Type: BIOLOGICAL; Name: intra venous injection of stem cell; Assigned to Arm(s): stem cell reciepient
B: Arm Label: Treatment with autologous mesenchymal stem cells (MSC) intrathecally and intravenously; Type: EXPERIMENTAL; Interventions: Biological: Injection of autologous bone marrow derived mesenchymal stem cells | Intervention Type: BIOLOGICAL; Name: Injection of autologous bone marrow derived mesenchymal stem cells; Assigned to Arm(s): Treatment with autologous mesenchymal stem cells (MSC) intrathecally and intravenously
C: Arm Label: Transplant; Type: EXPERIMENTAL; Interventions: Procedure: Laminectomy and bone marrow stem cells transplantation, Procedure: Autologous bone marrow cells collection | Intervention Type: PROCEDURE; Name: Laminectomy and bone marrow stem cells transplantation; Assigned to Arm(s): Transplant | Intervention Type: PROCEDURE; Name: Autologous bone marrow cells collection; Assigned to Arm(s): Transplant
D: Arm Label: MSC-NTF cells IM; Type: EXPERIMENTAL; Interventions: Biological: MSC-NTF cells transplantation (IM) | Arm Label: MSC-NTF cells IT; Type: EXPERIMENTAL; Interventions: Biological: MSC-NTF cells transplantation (IT) | Intervention Type: BIOLOGICAL; Name: MSC-NTF cells transplantation (IM); Assigned to Arm(s): MSC-NTF cells IM | Intervention Type: BIOLOGICAL; Name: MSC-NTF cells transplantation (IT); Assigned to Arm(s): MSC-NTF cells IT

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal Women
Brief Summary: To determine the effect of increasing serum 25(OH)D from prevailing levels with vitamin D3 supplementation, while maintaining adequate calcium intake, on incidence of all-type cancer in a population sample of healthy postmenopausal women.


Options:
A: Arm Label: Vitamin E + selenium placebo; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Other: selenium placebo | Arm Label: Selenium + vitamin E placebo; Type: EXPERIMENTAL; Interventions: Drug: Selenium, Other: Vitamin E placebo | Arm Label: Vitamin E + selenium; Type: EXPERIMENTAL; Interventions: Drug: Vitamin E, Drug: Selenium | Arm Label: Vitamin E placebo + selenium placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Vitamin E placebo, Other: selenium placebo | Intervention Type: DRUG; Name: Vitamin E; Assigned to Arm(s): Vitamin E + selenium, Vitamin E + selenium placebo | Intervention Type: DRUG; Name: Selenium; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E + selenium | Intervention Type: OTHER; Name: Vitamin E placebo; Assigned to Arm(s): Selenium + vitamin E placebo, Vitamin E placebo + selenium placebo | Intervention Type: OTHER; Name: selenium placebo; Assigned to Arm(s): Vitamin E + selenium placebo, Vitamin E placebo + selenium placebo
B: Arm Label: 1; Type: N/A; Interventions: N/A | Arm Label: 2; Type: N/A; Interventions: N/A | Arm Label: 3; Type: N/A; Interventions: N/A | Arm Label: 4; Type: N/A; Interventions: N/A
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Dietary Supplement: calcium supplementation | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Dietary Supplement: calcium and vitamin D3 supplementation | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: calcium supplementation; Assigned to Arm(s): 1 | Intervention Type: DIETARY_SUPPLEMENT; Name: calcium and vitamin D3 supplementation; Assigned to Arm(s): 2 | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): 3
D: Arm Label: vitamin D3 and calcium carbonate; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonate | Arm Label: Placebo for vitamin D3 and calcium carbonate; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonate | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Placebo for vitamin D3 and calcium carbonate, vitamin D3 and calcium carbonate | Intervention Type: DIETARY_SUPPLEMENT; Name: Calcium carbonate; Assigned to Arm(s): Placebo for vitamin D3 and calcium carbonate, vitamin D3 and calcium carbonate

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder.
Brief Summary: This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.


Options:
A: Arm Label: Structured patient visits; Type: OTHER; Interventions: Behavioral: Structured patient-centered follow up of depression | Arm Label: Treatment as usual; Type: OTHER; Interventions: Behavioral: Structured patient-centered follow up of depression | Intervention Type: BEHAVIORAL; Name: Structured patient-centered follow up of depression; Assigned to Arm(s): Structured patient visits, Treatment as usual
B: Arm Label: WHI; Type: EXPERIMENTAL; Interventions: Behavioral: Work and Health Initiative | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual Medical or Behavioral Intervention | Intervention Type: BEHAVIORAL; Name: Work and Health Initiative; Assigned to Arm(s): WHI | Intervention Type: BEHAVIORAL; Name: Usual Medical or Behavioral Intervention; Assigned to Arm(s): Usual Care
C: Arm Label: Desvenlafaxine succinate sustained-release 50 mg; Type: EXPERIMENTAL; Interventions: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR) | Arm Label: Desvenlafaxine succinate sustained-release 100 mg; Type: EXPERIMENTAL; Interventions: Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Duloxetine 60mg; Type: OTHER; Interventions: Drug: Duloxetine 60 mg/day | Intervention Type: DRUG; Name: Desvenlafaxine Succinate Sustained-Release (DVS SR); Assigned to Arm(s): Desvenlafaxine succinate sustained-release 50 mg | Intervention Type: DRUG; Name: Desvenlafaxine Succinate Sustained-Release (DVS SR); Assigned to Arm(s): Desvenlafaxine succinate sustained-release 100 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Duloxetine 60 mg/day; Assigned to Arm(s): Duloxetine 60mg
D: Arm Label: Brexipiprazole + ADT; Type: EXPERIMENTAL; Interventions: Drug: OPC-34712, Drug: Placebo, Drug: ADT | Arm Label: Placebo + ADT; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: ADT | Intervention Type: DRUG; Name: OPC-34712; Assigned to Arm(s): Brexipiprazole + ADT | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Brexipiprazole + ADT, Placebo + ADT | Intervention Type: DRUG; Name: ADT; Assigned to Arm(s): Brexipiprazole + ADT, Placebo + ADT

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg?
Brief Summary: It has been previously demonstrated that the risk for the development of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se, the surgery, or whether the development of knee osteoarthritis is completely independent of the two. Accordingly, the aim of the study is to investigate the effect of arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure.


Options:
A: Arm Label: Arthroscopic Partial Meniscectomy; Type: EXPERIMENTAL; Interventions: Procedure: Arthroscopic Partial Meniscectomy | Arm Label: Physical Therapy; Type: ACTIVE_COMPARATOR; Interventions: Other: Physical Therapy | Intervention Type: PROCEDURE; Name: Arthroscopic Partial Meniscectomy; Assigned to Arm(s): Arthroscopic Partial Meniscectomy | Intervention Type: OTHER; Name: Physical Therapy; Assigned to Arm(s): Physical Therapy
B: Arm Label: Arthroscopic partial meniscectomy; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Arthroscopic partial meniscectomy | Arm Label: Arthroscopy (diagnostic); Type: SHAM_COMPARATOR; Interventions: Procedure: Arthroscopy (diagnostic) | Intervention Type: PROCEDURE; Name: Arthroscopic partial meniscectomy; Assigned to Arm(s): Arthroscopic partial meniscectomy | Intervention Type: PROCEDURE; Name: Arthroscopy (diagnostic); Assigned to Arm(s): Arthroscopy (diagnostic)
C: Arm Label: Arthroscopy; Type: EXPERIMENTAL; Interventions: Procedure: Arthroscopic meniscal repair or resection | Arm Label: Exercise and Education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Exercise and education | Intervention Type: PROCEDURE; Name: Arthroscopic meniscal repair or resection; Assigned to Arm(s): Arthroscopy | Intervention Type: BEHAVIORAL; Name: Exercise and education; Assigned to Arm(s): Exercise and Education
D: Arm Label: Arthroscopy plus Medical Management; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Arthroscopy plus Medical Management, Other: Medical Management | Arm Label: Medical Management; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Arthroscopy plus Medical Management; Assigned to Arm(s): Arthroscopy plus Medical Management | Intervention Type: OTHER; Name: Medical Management; Assigned to Arm(s): Arthroscopy plus Medical Management

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: Arm Label: Intravenous immunoglobulin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Intravenous immunoglobulin | Arm Label: Hyperimmune intravenous immunoglobulin; Type: EXPERIMENTAL; Interventions: Drug: Hyperimmune intravenous immunoglobulin | Intervention Type: DRUG; Name: Hyperimmune intravenous immunoglobulin; Assigned to Arm(s): Hyperimmune intravenous immunoglobulin | Intervention Type: DRUG; Name: Intravenous immunoglobulin; Assigned to Arm(s): Intravenous immunoglobulin
B: Arm Label: High-titer anti-influenza plasma; Type: EXPERIMENTAL; Interventions: Biological: High-titer anti-influenza plasma | Arm Label: Low-titer anti-influenza plasma; Type: ACTIVE_COMPARATOR; Interventions: Biological: Low-titer anti-influenza plasma | Intervention Type: BIOLOGICAL; Name: High-titer anti-influenza plasma; Assigned to Arm(s): High-titer anti-influenza plasma | Intervention Type: BIOLOGICAL; Name: Low-titer anti-influenza plasma; Assigned to Arm(s): Low-titer anti-influenza plasma
C: Arm Label: Arm A: hIVIG; Type: EXPERIMENTAL; Interventions: Biological: Intravenous hyperimmune immunoglobulin (IVIG) | Arm Label: Arm B: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo for IVIG | Intervention Type: BIOLOGICAL; Name: Intravenous hyperimmune immunoglobulin (IVIG); Assigned to Arm(s): Arm A: hIVIG | Intervention Type: BIOLOGICAL; Name: Placebo for IVIG; Assigned to Arm(s): Arm B: Placebo
D: Arm Label: Plasma and Standard Care; Type: EXPERIMENTAL; Interventions: Biological: Anti-Influenza Immune Plasma, Drug: Standard Care | Arm Label: Standard Care; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard Care | Intervention Type: BIOLOGICAL; Name: Anti-Influenza Immune Plasma; Assigned to Arm(s): Plasma and Standard Care | Intervention Type: DRUG; Name: Standard Care; Assigned to Arm(s): Plasma and Standard Care, Standard Care

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: Arm Label: Convalescent plasma group; Type: EXPERIMENTAL; Interventions: Biological: Convalescent plasma, Drug: Hydroxychloroquin with Azithromycin | Arm Label: Control group; Type: OTHER; Interventions: Drug: Hydroxychloroquin with Azithromycin | Intervention Type: BIOLOGICAL; Name: Convalescent plasma; Assigned to Arm(s): Convalescent plasma group | Intervention Type: DRUG; Name: Hydroxychloroquin with Azithromycin; Assigned to Arm(s): Control group, Convalescent plasma group
B: Arm Label: Plasma and Standard Care; Type: EXPERIMENTAL; Interventions: Biological: Anti-Influenza Immune Plasma, Drug: Standard Care | Arm Label: Standard Care; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard Care | Intervention Type: BIOLOGICAL; Name: Anti-Influenza Immune Plasma; Assigned to Arm(s): Plasma and Standard Care | Intervention Type: DRUG; Name: Standard Care; Assigned to Arm(s): Plasma and Standard Care, Standard Care
C: Arm Label: Early COVID-19 convalescent plasma; Type: EXPERIMENTAL; Interventions: Biological: COVID-19 convalescent plasma | Arm Label: COVID-19 convalescent plasma; Type: EXPERIMENTAL; Interventions: Biological: COVID-19 convalescent plasma | Intervention Type: BIOLOGICAL; Name: COVID-19 convalescent plasma; Assigned to Arm(s): COVID-19 convalescent plasma, Early COVID-19 convalescent plasma
D: Arm Label: Treatment Group; Type: EXPERIMENTAL; Interventions: Other: convalescent plasma from recovered COVID 19 donor | Arm Label: control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: convalescent plasma from recovered COVID 19 donor; Assigned to Arm(s): Treatment Group

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: Arm Label: High-titer anti-influenza plasma; Type: EXPERIMENTAL; Interventions: Biological: High-titer anti-influenza plasma | Arm Label: Low-titer anti-influenza plasma; Type: ACTIVE_COMPARATOR; Interventions: Biological: Low-titer anti-influenza plasma | Intervention Type: BIOLOGICAL; Name: High-titer anti-influenza plasma; Assigned to Arm(s): High-titer anti-influenza plasma | Intervention Type: BIOLOGICAL; Name: Low-titer anti-influenza plasma; Assigned to Arm(s): Low-titer anti-influenza plasma
B: Arm Label: Arm A: hIVIG; Type: EXPERIMENTAL; Interventions: Biological: Intravenous hyperimmune immunoglobulin (IVIG) | Arm Label: Arm B: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo for IVIG | Intervention Type: BIOLOGICAL; Name: Intravenous hyperimmune immunoglobulin (IVIG); Assigned to Arm(s): Arm A: hIVIG | Intervention Type: BIOLOGICAL; Name: Placebo for IVIG; Assigned to Arm(s): Arm B: Placebo
C: Arm Label: Plasma and Standard Care; Type: EXPERIMENTAL; Interventions: Biological: Anti-Influenza Immune Plasma, Drug: Standard Care | Arm Label: Standard Care; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard Care | Intervention Type: BIOLOGICAL; Name: Anti-Influenza Immune Plasma; Assigned to Arm(s): Plasma and Standard Care | Intervention Type: DRUG; Name: Standard Care; Assigned to Arm(s): Plasma and Standard Care, Standard Care
D: Arm Label: treated; Type: EXPERIMENTAL; Interventions: Other: hyperimmune plasma | Intervention Type: OTHER; Name: hyperimmune plasma; Assigned to Arm(s): treated

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: Arm Label: Plasma and Standard Care; Type: EXPERIMENTAL; Interventions: Biological: Anti-Influenza Immune Plasma, Drug: Standard Care | Arm Label: Standard Care; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard Care | Intervention Type: BIOLOGICAL; Name: Anti-Influenza Immune Plasma; Assigned to Arm(s): Plasma and Standard Care | Intervention Type: DRUG; Name: Standard Care; Assigned to Arm(s): Plasma and Standard Care, Standard Care
B: Arm Label: Convalescent Plasma; Type: EXPERIMENTAL; Interventions: Biological: Convalescent plasma | Intervention Type: BIOLOGICAL; Name: Convalescent plasma; Assigned to Arm(s): Convalescent Plasma
C: Arm Label: High-Titer (CCP1); Type: EXPERIMENTAL; Interventions: Biological: High-titer Convalescent COVID-19 Plasma (CCP1) | Arm Label: Standard-Titer (CCP2); Type: ACTIVE_COMPARATOR; Interventions: Biological: Standard-titer Convalescent COVID-19 plasma (CCP2) | Intervention Type: BIOLOGICAL; Name: High-titer Convalescent COVID-19 Plasma (CCP1); Assigned to Arm(s): High-Titer (CCP1) | Intervention Type: BIOLOGICAL; Name: Standard-titer Convalescent COVID-19 plasma (CCP2); Assigned to Arm(s): Standard-Titer (CCP2)
D: Arm Label: treated; Type: EXPERIMENTAL; Interventions: Other: hyperimmune plasma | Intervention Type: OTHER; Name: hyperimmune plasma; Assigned to Arm(s): treated

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Open-Label, Phase 2, Multicenter Safety and Exploratory Efficacy Study of Investigational Anti-Influenza Immune Plasma for the Treatment of Influenza (IRC002)
Brief Summary: This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation. This study will enroll adults, children and pregnant women.


Options:
A: Arm Label: Convalescent plasma; Type: EXPERIMENTAL; Interventions: Biological: Convalescent plasma | Arm Label: Standard of care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BIOLOGICAL; Name: Convalescent plasma; Assigned to Arm(s): Convalescent plasma
B: Arm Label: Convalescent Plasma; Type: EXPERIMENTAL; Interventions: Biological: Convalescent Plasma | Arm Label: Standard of care; Type: OTHER; Interventions: Other: Standard of Care | Intervention Type: BIOLOGICAL; Name: Convalescent Plasma; Assigned to Arm(s): Convalescent Plasma | Intervention Type: OTHER; Name: Standard of Care; Assigned to Arm(s): Standard of care
C: Arm Label: Treatment Arm; Type: EXPERIMENTAL; Interventions: Other: Blood and derivatives. | Arm Label: Control Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard of Care | Intervention Type: OTHER; Name: Blood and derivatives.; Assigned to Arm(s): Treatment Arm | Intervention Type: DRUG; Name: Standard of Care; Assigned to Arm(s): Control Arm
D: Arm Label: Plasma and Standard Care; Type: EXPERIMENTAL; Interventions: Biological: Anti-Influenza Immune Plasma, Drug: Standard Care | Arm Label: Standard Care; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard Care | Intervention Type: BIOLOGICAL; Name: Anti-Influenza Immune Plasma; Assigned to Arm(s): Plasma and Standard Care | Intervention Type: DRUG; Name: Standard Care; Assigned to Arm(s): Plasma and Standard Care, Standard Care

Answer: D